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K Number
K241111
Device Name
AMT Suture Passer
Manufacturer
Applied Medical Technology, Inc.
Date Cleared
2024-07-05

(74 days)

Product Code
GCJGATKGC
Regulation Number
876.1500
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.
Device Description
The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.
More Information

K980123, K193612, K192490, K182832

K193612

No
The description focuses on mechanical and magnetic components for suture passing. There is no mention of AI, ML, image processing, or software that would suggest the use of such technologies. The "Software: Not applicable" section further confirms this.

No.
The device is indicated to pass suture, which is a surgical tool, not a therapeutic agent or device that treats or cures a disease or condition itself.

No

The device is primarily a suture grasping and passing device for surgical procedures. While it allows for contrast administration to verify needle position, this function is an auxiliary aid for a procedural step, not a diagnostic interpretation of patient data for disease detection or assessment.

No

The device description clearly outlines a physical, hand-held suture grasping device with a needle, retrieval components (magnetic and non-magnetic), and Luer-lock compatible hubs. The performance studies section explicitly states "Software: Not applicable."

Based on the provided information, the AMT Suture Passer is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to "pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures." This describes a surgical tool used in vivo (within the body) for a procedural purpose.
  • Device Description: The description details a hand-held suture grasping device with a needle and retrieval components. This is consistent with a surgical instrument, not a device used to examine specimens in vitro (outside the body).
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostic testing.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The AMT Suture Passer's function is purely mechanical and procedural within the body.

N/A

Intended Use / Indications for Use

The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

Product codes

GCJ

Device Description

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissues of the body

Indicated Patient Age Range

child, adolescent and adult populations

Intended User / Care Setting

Surgeons trained in endoscopic, and/or laparoscopic techniques and/or interventional radiologists.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

  • Biocompatibility Testing: Followed a Biological Evaluation Plan and tested for biocompatibility based on ISO 10993-1, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-23, USP-NF M98830 02 01 Bacterial Endotoxins Test, and USP-NF M98910 01 01 Medical Devices - Bacterial Endotoxin and Pyrogen Tests. The AMT Suture Passer met acceptance criteria for limited contact (24 hours or less) with tissue/bone/dentin. The suture component met acceptance criteria for prolonged contact (greater than 24 hours to 30 days) with tissue/bone/dentin.
  • Software: Not applicable.
  • Electromagnetic Compatibility & Electrical Safety: Not applicable.
  • Performance Testing:
    • Sterilization: Tested per ISO 10993-7. Validated to confirm a Sterility Assurance Level (SAL) of 10-6.
    • Shelf Life: Tested per ISO 11607-1 & 2 and ISTA 3A 2018. Validated shelf life of three (3) years.
    • Bench Testing: Tested per ISO 7864, ISO 9626, USP-NF M99670 02 01 Tensile Strength, USP-NF M99660 03 01 Sutures Needle Attachment, ISO 80369-1, and ISO 80369-7. Met or exceeded all acceptance criteria.
  • Animal Study: Not performed.
  • Clinical Study: Not performed.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K980123, K193612, K192490, K182832

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

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July 5, 2024

Applied Medical Technology, Inc. Jennifer Hazou Regulatory Affairs Specialist 8006 Katherine Blvd. Brecksville, Ohio 44141

Re: K241111

Trade/Device Name: AMT Suture Passer Regulation Number: 21 CFR 21 CFR 876.1500 Regulation Name: Laparoscope, General & Plastic Surgery Regulatory Class: Class II Product Code: GCJ Dated: April 22, 2024 Received: April 22, 2024

Dear Jennifer Hazou:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrb/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

1

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Digitally signed by Long H. Chen
Long H. Chen -S-S
Date: 2024.07.05 10:56:26 -04'00'

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241111

Device Name

AMT Suture Passer

Indications for Use (Describe)

The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

AMT Suture Passer

I. SUBMITTER:

Applied Medical Technology, Inc. 8006 Katherine Boulevard Brecksville, OH 44141 Phone: 440-717-4000 Fax: 440-717-4200

Contact Person: Jennifer Hazou - Regulatory Affairs Specialist Email: Jennifer.Hazou@appliedmedical.net Date Prepared: June 25, 2024

II. DEVICE INFORMATION:

Trade/Device Name: AMT Suture Passer Common Name: Laparoscope, General & Plastic Surgery Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope, General & Plastic Surgery Regulatory Class: II Product Code: GCJ

III. PREDICATE INFORMATION:

Carter-Thomason Predicate: K980123 (Needle Point Suture Passer Instrument Set - CTSG; Carter-Thomason)

AMT Predicate Device: K193612 (Suture Delivery System; Applied Medical Technology, Inc.)

Teleflex Predicate Device: K192490 (Cottony II Polyester Suture; Teleflex Medical)

Cook Predicate Device: K182832 (Cope Pediatric Gastrointestinal Suture Anchor Set & Enterostomy Suture Anchor Set; Cook Incorporated)

** The predicate devices have not been subject to design-related recalls.

IV. INDICATIONS FOR USE:

The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

DEVICE DESCRIPTION: V.

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a

4

magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional Ustitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit.

For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications.

Both configurations of the AMT Suture Passer feature identical components, except for the endeffectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATES:

| | | Subject | Carter-Thomason
Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | AMT Suture Passer
(KXXXXXX) | Carter-Thomason SG
Suture Passer
(K980123) | ATLAS Suture Delivery
System
(K193612) | Cottony II Suture
(K153076, K021019,
K192490) | Cope Enterostomy
Suture Anchor Set and
Cope Pediatric
Gastrointestinal Suture
Anchor Set (K182832) | Comparison |
| Classification | Device
Classification | Class II | Class II | Class II | Class II | Class II | SAME AS PREDICATE |
| | Product Codes | GCJ | GCJ | KGC | GAT | KGC | The subject device has the
same classification and product
code as the predicate. |
| | Regulation No. | 876.1500 | 876.1500 | 876.5980 | 878.5000 | 876.5980 | |
| | Panel | General & Plastic
Surgery | General & Plastic
Surgery | Gastroenterology/
Urology | General & Plastic
Surgery | Gastroenterology/
Urology | |
| Sterility | Condition | Provided sterile | Provided sterile | Provided sterile | Provided sterile | Provided sterile | SAME AS PREDICATE |
| | Reprocessing | Single use only; not re-
processable | Single use only; not re-
processable | Single use only; not re-
processable | Single use only; not re-
processable | Single use only; not re-
processable | The subject device and
predicate devices are sterile,
single-use devices that are not
re-processable. Sterilization
method (EO) is the same and
similar packaging is employed,
including a tray for organization,
and a peel-open Tyvek lid to
maintain the sterile barrier. The
subject device also uses a
pouch, which provides a
second sterile barrier. |
| | Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide | |
| | Packaging | Tray w/peel-open
Tyvek lid inside peel-
open Tyvek pouch | Tray w/ peel-open
Tyvek lid | Tray w/peel-open
Tyvek lid inside peel-
open Tyvek pouch | Peel-open paper
packet inside peel-open
Tyvek pouch | Peel-open Tyvek
Pouch | |
| | Assurance
Level | SAL 10-6 | SAL 10-6 | SAL 10-6 | SAL 10-6 | SAL 10-6 | |
| | | Subject | Carter-Thomason
Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | Comparison |
| | | AMT Suture Passer
(KXXXXXX) | Carter-Thomason SG
Suture Passer
(K980123) | ATLAS Suture Delivery
System
(K193612) | Cottony II Suture
(K153076, K021019,
K192490) | Cope Enterostomy
Suture Anchor Set and
Cope Pediatric
Gastrointestinal Suture
Anchor Set (K182832) | |
| | Prescription | Prescription Only | Prescription Only | Prescription Only | Prescription Only | Prescription Only | SAME AS PREDICATE |
| User Population | Intended User | Surgeons trained in
endoscopic, and/or
laparoscopic
techniques and/or
interventional
radiologists. | Surgeons trained in
endoscopic and/or
laparoscopic
techniques | Surgeons trained in
endoscopic techniques | Various clinicians
trained in the use of
sutures | Surgeons,
gastrointestinal doctors,
and interventional
radiologists | The subject device and the
predicate devices are
prescription only devices that
serve the same user
populations. |
| Clinical Application | Indications for
Use | Indicated to pass
suture through soft
tissues of the body
during
endoscopic/laparoscopi
c surgery and
interventional radiology
procedures in child,
adolescent and adult
populations. | Indicated to pass
suture through soft
tissues of the body
during endoscopic/
laparoscopic surgery | Intended for anchoring
the wall of a hollow
viscus to the abdominal
wall prior to the
introduction of
interventional catheters
and stay in place for up
to 14 days, in child,
adolescent, and adult
populations | Indicated for use in
general soft tissue
approximation and/or
ligation, including use
in
cardiovascular,
ophthalmic, orthopedic
and neurological
procedures | Intended for anchoring
the wall of a hollow
viscus to the abdominal
wall prior to the
introduction of
interventional catheters
and stay in place for up
to 14 days | SIMILAR TO PREDICATE
The subject device differs from
the predicate in the addition of
interventional radiology
procedures to the indications
for use, and in the inclusion of
the patient population in the
indications for use. |
| | Intended Use | Passes a suture
through soft tissues of
the body | Passes a suture
through soft tissues of
the body | Passes a suture
through soft tissues of
the body for the
purpose of securing a
hollow viscus to the
anterior abdominal wall | Approximation and/or
ligation of soft tissues | Delivers a suture with a
metal anchor through
soft tissues of the body
for the purpose of
securing the stomach
to anterior the
abdominal wall | Expansion of the indication to
IR procedures is supported
because the subject device
allows contrast to be injected
through the device. |
| | | Subject | Carter-Thomason
Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | |
| | | AMT Suture Passer
(KXXXXXX) | Carter-Thomason SG
Suture Passer
(K980123) | ATLAS Suture Delivery
System
(K193612) | Cottony II Suture
(K153076, K021019,
K192490) | Cope Enterostomy
Suture Anchor Set and
Cope Pediatric
Gastrointestinal Suture
Anchor Set (K182832) | Comparison |
| | Procedural Use | General surgery | General surgery | Pexy procedures (e.g.,
gastropexy, jejunopexy,
cystopexy, etc.) | General surgery
(including
cardiovascular,
ophthalmic, orthopedic
and neurological
procedures) | Gastropexy | The addition of the patient
population to the indications is
keeping in line with current best
practices for device labeling. |
| | Device | Not MR-safe | Not MR-safe | Not MR-safe | N/A - SUTURE ONLY | Not MR-safe | SAME AS PREDICATE |
| MR Safety | Suture | For the configuration
which features
magnetically assisted
end-effectors, suture is
MR-safe after magnet
head is removed | *Suture not included,
but required in
accordance with
labeling. Suture is MR-
safe after needle is
removed. | Suture is MR-safe after
magnet head is
removed | Suture is MR-safe after
needle is removed | Suture is MR-
conditional due to metal
T-bar anchor that
remains inside the
patient after placement | Neither the subject device nor
the predicate devices are MR-
safe. Suture placed using any
of the devices is MR-safe when
placed in accordance with the
labeling. |
| Configurations | Instrument
Kit(s) | For the configuration
which features
magnetically assisted
end-effectors, YES -
AMT Suture Passer Kit | For the configuration
that features port
closure elements, YES

  • Carter-Thomason II
    Port Closure System | NO | NO | YES - Gastropexy Kit | SIMILAR TO PREDICATE
    The subject device uses a small
    gauge needle that is shorter
    than the predicate and may be
    offered in curved
    configurations. |
    | | Needle Sizes | 17-gauge: May be
    offered curved or
    straight, depending on
    configuration. | 14-gauge | 17-gauge | Multiple sizes:
    Needle size scales with
    suture size | 18-gauge | The subject device utilizes an
    echogenic treatment on the
    needle. |
    | Technological
    Characteristics | | Subject | Carter-Thomason
    Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | |
    | | | AMT Suture Passer
    (KXXXXXX) | Carter-Thomason SG
    Suture Passer
    (K980123) | ATLAS Suture Delivery
    System
    (K193612) | Cottony II Suture
    (K153076, K021019,
    K192490) | Cope Enterostomy
    Suture Anchor Set and
    Cope Pediatric
    Gastrointestinal Suture
    Anchor Set (K182832) | Comparison |
    | | Needle Length | 2.5 in. [6.35 cm] | 8.3 in. [120.82 cm] | 2.5 in. [6.35 cm] | Multiple sizes available
    (needle size scales
    relative to suture size) | 7 cm | Suture is included with one
    configuration of the subject
    device, but must be furnished
    by the user with the other and
    the predicate. |
    | | Needle Type | Hypodermic (hollow,
    round cross-section) | Hypodermic (hollow,
    round cross-section) | Hypodermic (hollow,
    round cross-section) | Solid, available in
    multiple cross-sectional
    shapes | Hypodermic (hollow,
    round cross-section) | the predicate. |
    | | Needle Finish | As-drawn; echogenic
    treatment | As-drawn | As-drawn | Machined/ground | As-drawn | |
    | | Suture Size | For the configuration
    which features
    magnetically assisted
    end-effectors, USP 3-0 | *Suture not included.
    Recommended size is
    USP 1 | USP 3-0 | USP 7-0 through 9 | USP 2-0 | |
    | | Design
    Archetype | Grasper-type suture
    passer | Grasper-type suture
    passer | Magnetic suture passer | Surgical suture | T-bar suture anchor | SIMILAR TO PREDICATE
    Both the subject device and the |
    | | Operational
    Style | Hand-held; manually
    operated / no external
    power source | Hand-held; manually
    operated / no external
    power source | Hand-held; manually
    operated / no external
    power source | Hand-held; manually
    operated / no external
    power source | Hand-held; manually
    operated / no external
    power source | Carter-Thomason predicate
    device follow the same design
    archetype and have the same
    operational style. Both devices |
    | | Suture
    Securement
    Method | Suture mechanically
    trapped between
    grasper and wall of
    needle | Suture mechanically
    trapped between
    grasper and wall of
    needle | Suture coupled to
    retriever by magnetic
    connection | Manual (needle driver,
    etc.) | N/A (suture is not
    retrieved using device) | utilize similar means of suture
    securement, and both work with
    standard surgical sutures. |
    | Subject | Carter-Thomason
    Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | Comparison | | |
    | AMT Suture Passer
    (KXXXXXX) | Carter-Thomason SG
    Suture Passer
    (K980123) | ATLAS Suture Delivery
    System
    (K193612) | Cottony II Suture
    (K153076, K021019,
    K192490) | Cope Enterostomy
    Suture Anchor Set and
    Cope Pediatric
    Gastrointestinal Suture
    Anchor Set (K182832) | | | |
    | Compatible
    Suture | Compatible with
    standard surgical
    sutures and magnetic
    sutures, depending
    upon configuration | Compatible with
    standard surgical
    sutures | Compatible with
    included magnetic
    suture | N/A | Compatible with
    included T-bar suture | The subject device differs from
    the Carter-Thomason predicate
    in the use of magnet technology
    and provision for fluid exchange
    through the device. | |
    | Suture
    Specification | For the configuration
    which features
    magnetically assisted
    end-effectors, USP 3-0,
    polyester, braided,
    nonabsorbable,
    magnetic head | *Suture not included
    (USP size 1
    recommended) | USP 3-0, polyester,
    braided,
    nonabsorbable,
    magnetic head | USP 7-0 through 9,
    polyester, braided,
    nonabsorbable, needle
    head | USP 3-0, Byosyn,
    monofilament,
    absorbable, T-bar head | | |
    | Magnet
    Technology | ONLY for the
    configuration which
    features magnetically
    assisted end-effectors -
    small permanent gold-
    plated magnets
    (NdFeB) incorporated
    into grasper arm and
    suture head | NO | Small permanent gold-
    plated magnets
    (NdFeB) incorporated
    into retriever arm and
    suture head | NO | NO | | |
    | Fluid Exchange | Luer-lock compatible
    hub for syringe
    attachment; patent
    lumen through device | NO | NO | N/A | Luer-lock compatible
    hub for syringe
    attachment; patent
    lumen through device | | |
    | | | Subject | Carter-Thomason
    Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | |
    | | | AMT Suture Passer
    (KXXXXXX) | Carter-Thomason SG
    Suture Passer
    (K980123) | ATLAS Suture Delivery
    System
    (K193612) | Cottony II Suture
    (K153076, K021019,
    K192490) | Cope Enterostomy
    Suture Anchor Set and
    Cope Pediatric
    Gastrointestinal Suture
    Anchor Set (K182832) | Comparison |
    | Construction | Main
    Components | • Instrument body w/
    hypodermic
    needle(s)
    • Grasper assembly
    • Lock assembly
    • Suture with magnet
    head, for the
    configuration which
    features
    magnetically
    assisted end-
    effectors | • Instrument body w/
    hypodermic needle
    • Grasper assembly
    • Port-closure
    elements ONLY with
    the Carter-
    Thomason II Port
    Closure System | • Instrument body w/
    hypodermic needles
    (2)
    • Magnetic suture
    delivery cannula
    assembly
    • Magnetic suture
    retrieval probe
    assembly
    • Suture with magnet
    head
    • Skin bumper | • Suture with needle
    head | • Instrument body w/
    hypodermic needle
    • T-bar suture delivery
    cannula assembly
    • Suture with T-bar
    head
    • Skin bumper/ suture
    clip | SIMILAR TO PREDICATE
    The main components that
    comprise the subject device are
    similar to the predicate, differing
    in the inclusion of magnetic
    sutures for the relevant
    configuration and a locking
    mechanism. |
    | | Materials of
    Construction | • 300-series Stainless
    steel
    • Nitinol
    • Thermoplastics
    • Adhesives
    • Gold-plated
    neodymium
    (magnets), ONLY for
    the configuration
    which features
    magnetically
    assisted end-
    effectors | • 300-series Stainless
    steel
    • Thermoplastics
    • Adhesives | • 300-series Stainless
    steel
    • Nitinol
    • Gold-plated
    neodymium
    (magnets)
    • Thermoplastics
    • Adhesives
    • Silicone | • 300- or 400-series
    Stainless steel or
    Maraging Steel
    • Thermoplastics | • 300-series Stainless
    steel
    • Thermoplastics
    • Bio-absorbable
    thermoplastics
    • Adhesives | |
    | | | Subject | Carter-Thomason
    Predicate | AMT Predicate | Cottony Predicate | Cope Predicate | |
    | | | AMT Suture Passer
    (KXXXXXX) | Carter-Thomason SG
    Suture Passer
    (K980123) | ATLAS Suture Delivery
    System
    (K193612) | Cottony II Suture
    (K153076, K021019,
    K192490) | Cope Enterostomy
    Suture Anchor Set and
    Cope Pediatric
    Gastrointestinal Suture
    Anchor Set (K182832) | Comparison |
    | Construction (Cont.) | Manufacturing
    Processes | Thermoplastic
    Injection Molding Thermoplastic
    Extrusion Progressive Die
    Stamping DOM Tube Forming Bending/ Coiling Filament Extrusion +
    Braiding Cutting/ Grinding/
    Machining Shape Setting Assembly with UV-
    Cured Adhesives Assembly with
    Cyanoacrylates Assembly without
    Adhesives Swaging/ Crimping Powdered
    Metallurgy + Gold
    Plating, ONLY for
    the configuration
    which features
    magnetically
    assisted end-
    effectors | Thermoplastic
    Extrusion Thermoplastic
    Injection Molding Metal Stamping DOM Tube Forming Bending/ Coiling Cutting/ Grinding/
    Machining Assembly with
    Adhesives Assembly without
    Adhesives | Thermoplastic
    Injection Molding Thermoplastic
    Extrusion Silicone Injection
    Molding Silicone Extrusion Progressive Die
    Stamping DOM Tube Forming Bending/ Coiling Filament Extrusion +
    Braiding Cutting/ Grinding/
    Machining Powdered
    Metallurgy + Gold
    Plating Autogenous Welding
  • Shape Setting Assembly with UV-
    Cured Adhesives Assembly with
    Cyanoacrylates Assembly without
    Adhesives Swaging/ Crimping | Filament Extrusion +
    Braiding Cutting/ Grinding/
    Machining Assembly without
    Adhesives Swaging/ Crimping | Thermoplastic
    Injection Molding Silicone Injection
    Molding DOM Tube Forming Filament Extrusion Cutting/ Grinding/
    Machining Assembly with
    Adhesives Assembly without
    Adhesives Swaging/ Crimping | SIMILAR TO PREDICATE
    The subject device employs
    manufacturing processes that
    are similar to the predicate
    devices.
    The differences that exist
    between the subject device and
    predicate device are related to
    the differences in components
    described above (e.g.,
    powdered metallurgy + gold
    plating relates to the
    construction of the permanent
    magnets, etc. ONLY for the
    configuration which features
    magnetically assisted end-
    effectors - components which
    are not found in the predicate
    device). |

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VII. PERFORMANCE DATA:

  • A. Biocompatibility Testing: Following a Biological Evaluation Plan, the AMT Suture Passer was tested for biocompatibility based on the applicable sections of the following standards:
    • . ISO 10993-1 Fifth edition 2018-08 - Biological evaluation of medical devices --Part 1: Evaluation and testing within a risk management process
    • ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices . --Part 5: Tests for in vitro cytotoxicity
    • ISO 10993-7 Second edition 2008-10-15 Biological evaluation of medical devices . --Part 7: Ethylene oxide sterilization residuals
    • ISO 10993-10 Fourth edition 2021-11 Biological evaluation of medical devices ● -- Part 10: Tests for skin sensitization
    • ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices ● --Part 11: Tests for systemic toxicity
    • ISO 10993-23 First edition 2021-01 Biological evaluation of medical devices ● --Part 23: Tests for irritation
    • . USP-NF M98830 02 01 Bacterial Endotoxins Test
    • USP-NF M98910 01 01 ● Medical Devices - Bacterial Endotoxin and Pyrogen Tests

It was determined that the AMT Suture Passer met the acceptance criteria for limited contact (24 hours or less) with tissue/bone/dentin. The suture component of the subject device met the acceptance criteria for prolonged contact (greater than 24 hours to 30 days) with tissue/bone/dentin.

  • B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device.
  • C. Electromagnetic Compatibility & Electrical Safety: There are no electronic components related in any way to this device.

D. Performance Testing:

1. Sterilization

Testing has been completed to evaluate the sterilization process for the subject device, and is outlined below:

  • Testing per ISO 10993-7. Second edition 2008-10-15 .
    • Biological evaluation of medical devices Part 7: Ethylene oxide sterilization o residuals

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The subject device is ethylene oxide sterilized, and has been validated to confirm a Sterility Assurance Level (SAL) of 106. The sterilization processing complies with the standards.

2. Shelf Life

Applicable shelf life testing was conducted in accordance with the following:

  • . Testing per ISO 11607-1 & 2. Second edition 2019-02:
    • o Packaging for terminally sterilized medical devices
  • Testing per ISTA 3A 2018: Packaged products for parcel delivery system shipment 70kg (150 lb) or less o

Testing indicates that the subject device has a validated shelf life of three (3) years.

3. Bench Testing

Bench tests have been carried out to demonstrate conformance to applicable recognized standards and to assure reliable design and performance under the specified testing parameters according to predetermined criteria. The tests carried out include:

  • Testing per ISO 7864 Fourth edition 2016-08-01 ●
    • Sterile hypodermic needles for single use Requirements and test methods o
  • . Testing per ISO 9626 Second edition 2016-08-01
    • Stainless steel needle tubing for the manufacture of medical devices -O Requirements and test methods
  • Testing per USP-NF M99670 02 01
    • Tensile Strength о
  • Testing per USP-NF M99660 03 01 ●
    • o Sutures Needle Attachment
  • Testing per ISO 80369-1 Second edition 2018-11 ●
    • Small-bore connectors for liquids and gases in healthcare applications Part 1: O General requirements
  • Testing per ISO 80369-7 Second edition 2021-05
    • Small-bore connectors for liquids and gases in healthcare applications Part 7: O Connectors for intravascular or hypodermic applications

The AMT Suture Passer met or exceeded all the acceptance criteria and does not raise new questions of safety or effectiveness when compared to the predicate.

  • E. Animal Study: Animal testing was NOT performed.
  • F. Clinical Study: Clinical testing was NOT performed.

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VIII. CONCLUSION:

The subject device is comparable in intended use, operative principles, materials of construction, methods of manufacture, and technology to the predicate devices and therefore do not raise new concerns regarding the safety or effectiveness of the subject device. Minor differences between the subject device and the predicate devices do not result in new concerns regarding safety and effectiveness, either. Therefore, the subject device may be claimed to be substantially equivalent to the predicate devices.