(177 days)
Not Found
No
The summary describes a mechanical injection needle and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is described as an "injection needle" used for injecting "various types of media" through endoscopes, and its predicate device is a "Sclerotherapy Needle." While sclerotherapy is a therapeutic procedure, the device itself is an instrument used to deliver substances, not a therapeutic device that inherently treats a condition.
No
The device description states it is intended for the "injection of various types of media through flexible endoscopes" into the gastrointestinal tract. This describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly outlines physical components such as needles, sheaths, tubes, and a handle, indicating it is a hardware medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "injection of various types of media through flexible endoscopes." This describes a procedure performed on the patient, not a test performed on a sample taken from the patient.
- Device Description: The description details a physical device used for injection, not a reagent, instrument, or system intended for the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are used to perform tests on samples like blood, urine, tissue, etc., to diagnose diseases or conditions. This device is used for delivering substances directly into the body during an endoscopic procedure.
N/A
Intended Use / Indications for Use
These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.
Product codes (comma separated list FDA assigned to the subject device)
FBK
Device Description
The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.
The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract. Once the device is unpackaged from the sterile packaging, the user can purge the needle assembly of air by attaching the injection container (i.e. a syringe) to the proximal luer and dispensing 0.5 - 0.75 ccs of media. After purging the device, the user ensures the needle is fully retracted into the catheter of the device by slowly twisting the proximal luer until it disengages from the distal luer. Once verified that the needle has been fully retracted into the catheter, the user threads the catheter through the working channel of the endoscope. Once the needle has been threaded through the endoscope and the injection site has been reached, the user can lock the needle into the deployed position by pressing the proximal luer against the distal luer and then turning the proximal luer until it stops. The needle can then be inserted into the mucosa of the gastrointestinal tract. Once the needle has been inserted, the desired injection media can be administered to the patient via the distal luer connection. Once injection is completed, the user can retract the needle by disengaging the proximal and distal luers and allowing the compression spring to pull the needle into the sheath or by physically grasping the proximal luer and pulling in the proximal direction until the needle enters the sheath (PN 00711808). Once the needle is retracted, the user can then remove the device from the endoscope.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gastrointestinal mucosa, digestive system, gastrointestinal tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Functional Testing:
Testing: Working Length, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Needle Deployment Length, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Needle Handle Luer Compatibility, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Luer Compatibility, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Needle Deployment Length After Cycles, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Device Insertion Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Device Extraction Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Pentax Needle Scope Compatibility, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Device Catheter Kink Criteria, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Ferrule to Needle Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: PEEK to Needle Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Handle Hypo Tube to PEEK Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Handle Hypo Tube to Luer Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Distal Hub to Spring Sheath Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Spring Sheath to Handle, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Handle Hypo Tube to Washer Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Male Handle to Female Handle Tensile Force, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Injection Force Gauge Comparison, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Needle Deployment Force & Retraction, Acceptance Criteria: Meet design requirements, Results: Pass
Testing: Needle Leakage Test, Acceptance Criteria: Meet design requirements, Results: Pass
Simulated Use Testing:
Testing: Endoscope Channel Compatibility, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Pentax Endoscope Compatibility, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Duodenoscope Compatibility, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Needle Deployment and Retraction, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Needle Deployment Lock, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Device Functions in a Straight and Articulated Position, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Needle Patency, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Duodenoscope Injection Compatibility, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Needle Penetration, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Leakage Requirement, Acceptance Criteria: Meet design requirements, Result: Pass
Testing: Device Maintains Structural Integrity, Acceptance Criteria: Meet design requirements, Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
March 8, 2024
STERIS Carroll Martin Director, Regulatory Affairs 5976 Heislev Rd Mentor, Ohio 44060
Re: K2328
Trade/Device Name: Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: FBK Dated: February 5, 2024 Received: February 6, 2024
Dear Carroll Martin:
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/cdrh/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
1
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).
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 QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 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 medical devices and radiation-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).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
| Articulator Injection Needle (00711807); |
|---|
| Articulator Injection Needle (00711810); |
| Articulator Injection Needle - enteroscope (00711808); |
| Carr-Locke Injection Needle (00711811); |
| Carr-Locke Injection Needle (00711812); |
| Carr-Locke Injection Needle (00711813); |
| Carr-Locke Injection Needle (00711814); |
| Carr-Locke Injection Needle (00711822); |
| Carr-Locke Injection Needle (00711823); |
| Carr-Locke Injection Needle (00711824) |
Indications for Use (Describe)
These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.
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.
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4
510(k) Summary For the Carr-Locke and Articulator Injection Needles K232826
STERIS Corporation 5960 Heisley Road Mentor, OH 44060 Phone: (440) 354-2600 Fax No: (440) 357-9198
Contact: Carroll Martin Director, Regulatory Affairs
Telephone: (440) 392-7437 Fax No: (440) 358-6259 e-mail: Carroll_Martin@steris.com
Summary Date: September 13, 2023
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K232826 Page 2 of 6
Device Name Articulator Injection Needle (00711807), Articulator Injection Needle (00711810), Articulator Injection Needle - enteroscope (00711808), Carr-Locke Injection Needle (00711811), Carr-Locke Injection Trade Name: Needle (00711812), Carr-Locke Injection Needle (00711813), Carr-Locke Injection Needle (00711814), Carr-Locke Injection Needle (00711822), Carr-Locke Injection Needle (00711823), Carr-Locke Injection Needle (00711824) Device Class: Class II Endoscopic Injection Needles Common/usual Name: Endoscope and accessories Regulation Name: 21 CFR 876.1500 Regulation Number: FBK Product Code:
2. Predicate Device
Sclerotherapy Needle K212668
Table 1. Device Comnarison Table for Carr-Locke and Articulator Needles and Predicate
| Feature | Sclerotherapy Needle
(Predicate Device/K212688) | Carr-Locke and Articulator
Needles
(Proposed Device) | Comparison |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The device is used for endoscopic
injection into gastrointestinal mucosa
or to endoscopically introduce a
sclerosing agent into selected sites to
control actual or potential bleeding
lesions in the digestive system | These single use, disposable, flexible
sheath injection needles are intended
to be used for the injection of various
types of media through flexible
endoscopes. | Similar. The
predicate device
mentions a sclerosing
agent, but this is a
type of media that is
injected into the
gastrointestinal tract,
which both devices
are intended to do. |
| Construction | Luer connector
Handle
Infusion tube
Sheath
Fixed button
Connection tube
Needle | Handle luer
Handle
Handle hypo tube
Compression spring (all needles
except P/N 00711808)
PEEK tube
Spring sheath
Distal hub
Injection needle | Similar. Although the
proposed devices
have a slightly
different design in
particular, the general
design of the devices,
a luer connection, a
handle, a sheath, a
tube through which
the media flows and a
needle are the same.
The slight differences
do not impact safety,
effectiveness or how
the device is used. |
| Sheath Diameter | 1.8mm and 2.4mm | 1.8mm and 2.5mm | Similar. The
differences in sheath
diameter between the
predicate and
proposed are minor.
This minor difference
does not impact |
| Feature | Sclerotherapy Needle
(Predicate Device/K212688) | Carr-Locke and Articulator
Needles | Comparison |
| | | (Proposed Device) | safety, effectiveness
or how the device is |
| | | | used. |
| Needle Size | 19 gauge
21 gauge
23 gauge
25 gauge | 23 gauge
25 gauge | Same |
| Working Length | 1200mm
1800mm
2000mm
2300mm | 2300mm
3500mm | Similar. The 3500mm
length of the
proposed device is to
allow the device to be
used in an
enteroscopy
endoscope. Testing
has shown that this
difference has not
impact on safety,
effectiveness or how
the device is used. |
| Packaging | Single-use EO sterilized paper-plastic
pouch with one device per pouch | Single-use EO sterilized Tyvek-
polyester/polyethylene film pouch.
All devices are packaged 5 devices to
a pouch except for P/Ns 00711810,
00711823 and 00711824 which are
packaged 10 to a pouch. | Similar. The
predicate and the
proposed devices are
packaged in sterilized
pouches. The larger
number of devices
packaged for the
proposed device does
not impact safety,
effectiveness or how
the devices are used. |
| Materials | Luer connector: ABS
Handle: ABS
Infusion tube: PP
Sheath: PTFE
Fixed button: Y12Cr18Ni9Cu3
Connection tube:
SUS304(06Cr19Ni10)
Needle:X5CrNi18-9 | Luer: polycarbonate
Male handle: ABS plastic with either
silver or white colorant
Female handle: ABS plastic with
either silver or white colorant
PEEK: 381G PEEK
Spring Sheath: 303 stainless steel
Spring Sheath coating (PNs
00711811,00711812,00711813,
00711814 and 00711822): PTFE
with green colorant
Handle hypo tube: 304 stainless steel
Distal hub: 303 stainless steel
Ferrule: 304 stainless steel
Compression spring: steel music wire | Similar. Both the
predicate and
proposed devices
contain stainless
steel, ABS plastic,
and PTFE. The main
difference is the
colorant present in
some of the proposed
devices, but testing
provided in this
submission show that
the colorant does not
impact safety,
effectiveness or how
the device is used. |
| Sterilization | Ethylene Oxide | Ethylene Oxide (SAL: 10-6) | Same |
| Method
Principle of
Operation | The catheter sheath of the
product is inserted into the
endoscope channel. When the front
part of the catheter sheath is placed | The user threads the catheter of the
device through the working channel
of the endoscope. Once the needle
has been threaded through the | Same |
| Feature | Sclerotherapy Needle
(Predicate Device/K212688) | Carr-Locke and Articulator
Needles
(Proposed Device) | Comparison |
| | on the lesion site, push the Luer
connector for injection, the needle is
exposed to the catheter sheath, and
the needle is inserted into the lesion
site, then drug injection. | endoscope and the injection site has
been reached, the user can lock the
needle into the deployed position by
pressing the proximal luer against
the distal luer and then turning the
proximal luer until it stops. The
needle can then be inserted into the
mucosa of the gastrointestinal tract.
Once the needle has been inserted,
the desired injection media can be
administered to the patient via the
distal luer connection. Once
injection is completed, the user can
retract the needle and remove the
device from the endoscope. | |
6
7
The proposed devices have the same intended use as the predicate with the same technological characteristics. Based on the testing in this submission, the minor physical differences do not impact safety, effectiveness or how the devices are used.
3. Description of Device
The Carr-Locke and Articulator Injection Needles are single use, disposable, flexible sheath injection needles that are intended to be used for the injection of various types of media through flexible endoscopes. All the needles have the same general design and consist of a handle luer, a handle hypo tube, a compression spring (except for PN 00711808), a PEEK tube, a spring sheath, a distal hub and an injection needle.
The Carr-Locke and Articulator needles are sterile, disposable devices that are used through the working channel of flexible endoscopes for the purpose of injecting media into the gastrointestinal tract. Once the device is unpackaged from the sterile packaging, the user can purge the needle assembly of air by attaching the injection container (i.e. a syringe) to the proximal luer and dispensing 0.5 - 0.75 ccs of media. After purging the device, the user ensures the needle is fully retracted into the catheter of the device by slowly twisting the proximal luer until it disengages from the distal luer. Once verified that the needle has been fully retracted into the catheter, the user threads the catheter through the working channel of the endoscope. Once the needle has been threaded through the endoscope and the injection site has been reached, the user can lock the needle into the deployed position by pressing the proximal luer against the distal luer and then turning the proximal luer until it stops. The needle can then be inserted into the mucosa of the gastrointestinal tract. Once the needle has been inserted, the desired injection media can be administered to the patient via the distal luer connection. Once injection is completed, the user can retract the needle by disengaging the proximal and distal luers and allowing the compression spring to pull the needle into the sheath or by
8
physically grasping the proximal luer and pulling in the proximal direction until the needle enters the sheath (PN 00711808). Once the needle is retracted, the user can then remove the device from the endoscope.
4. Intended Use/Indications for Use
These single use, disposable, flexible sheath injection needles are intended to be used for the injection of various types of media through flexible endoscopes.
ર. Summary of Nonclinical Tests
The Carr-Locke and Articulator Injection needles have a similar intended use and the same technological characteristics. The minor design differences and minor differences in intended use do not raise different questions of safety and effectiveness as compared to the predicate device. Testing to assess and demonstrate substantial equivalence to the predicate is summarized below:
| Functional Testing | |||
|---|---|---|---|
| Testing | Acceptance Criteria | Results | |
| Working Length | Meet design requirements | Pass | |
| Needle Deployment Length | Meet design requirements | Pass | |
| Needle Handle Luer Compatibility | Meet design requirements | Pass | |
| Luer Compatibility | Meet design requirements | Pass | |
| Needle Deployment Length After Cycles | Meet design requirements | Pass | |
| Device Insertion Force | Meet design requirements | Pass | |
| Device Extraction Force | Meet design requirements | Pass | |
| Pentax Needle Scope Compatibility | Meet design requirements | Pass | |
| Device Catheter Kink Criteria | Meet design requirements | Pass | |
| Ferrule to Needle Tensile Force | Meet design requirements | Pass | |
| PEEK to Needle Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to PEEK Tensile Force | Meet design requirements | Pass | |
| Handle Hypo Tube to Luer Tensile Force | Meet design requirements | Pass | |
| Distal Hub to Spring Sheath Tensile Force | Meet design requirements | Pass | |
| Spring Sheath to Handle | Meet design requirements | Pass | |
| Handle Hypo Tube to Washer Tensile Force | Meet design requirements | Pass | |
| Male Handle to Female Handle Tensile Force | Meet design requirements | Pass | |
| Injection Force Gauge Comparison | Meet design requirements | Pass | |
| Needle Deployment Force & Retraction | Meet design requirements | Pass | |
| Needle Leakage Test | Meet design requirements | Pass |
9
| Simulated Use Testing | |||
|---|---|---|---|
| Testing | Acceptance Criteria | Result | |
| Endoscope Channel Compatibility | Meet design requirements | Pass | |
| Pentax Endoscope Compatibility | Meet design requirements | Pass | |
| Duodenoscope Compatibility | Meet design requirements | Pass | |
| Needle Deployment and Retraction | Meet design requirements | Pass | |
| Needle Deployment Lock | Meet design requirements | Pass | |
| Device Functions in a Straight and Articulated Position | Meet design requirements | Pass | |
| Needle Patency | Meet design requirements | Pass | |
| Duodenoscope Injection Compatibility | Meet design requirements | Pass | |
| Needle Penetration | Meet design requirements | Pass | |
| Leakage Requirement | Meet design requirements | Pass | |
| Device Maintains Structural Integrity | Meet design requirements | Pass |
6. Conclusion
Based on the intended uses, technological characteristics and non-clinical performance data, the subject device is as safe, as effective and performs at least as well as the legally marketed predicate device K212668, Class II (21 CFR 876.1500), product code FBK.