(58 days)
Not Found
No
The device description and performance studies focus on mechanical function and bench testing, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used to place sutures in soft tissue, which is a therapeutic intervention to repair or close wounds.
No
Explanation for "No": The SpeedStitch System is described as an instrument for placing sutures through soft tissue during surgical procedures. Its function is to facilitate a therapeutic or operative action (suturing), not to diagnose a condition.
No
The device description clearly outlines physical components like a handle, needle cassette, and suture cartridge, indicating it is a hardware device, not software-only.
Based on the provided information, the SpeedStitch System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "placement of suture(s) through soft tissue in arthroscopic and limited access procedures." This describes a surgical instrument used directly on a patient's tissue for repair, not a device used to examine specimens from the body to provide diagnostic information.
- Device Description: The description clearly states it's an "orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue." This aligns with a surgical tool.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.) or to provide any diagnostic information about a patient's condition.
- Testing: The testing described is bench testing on a tissue model and simulated use, focusing on the mechanical function of delivering sutures. This is typical for surgical instruments, not IVDs which would involve testing with biological samples and evaluating diagnostic accuracy.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. The SpeedStitch System does not fit this description.
N/A
Intended Use / Indications for Use
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Product codes (comma separated list FDA assigned to the subject device)
GAT, NBH, HXK
Device Description
The SpeedStitch System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Bench testing was performed on both the proposed and predicate devices. This in vitro testing involved grasping of a tissue model with the suture passer, insertion of needles through the tissue model and capturing suture from suture cartridges, which was successfully pulled through the tissue model using the suture passer. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices (suture cartridges) which will be promoted for use with the SpeedStitch system in order to affirm safety and effectiveness.
The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling.
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
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The caduceus is depicted with three intertwined snakes and a pair of wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 6, 2017
ArthroCare Corporation Ms. Laura Kasperowicz Principle RA Specialist 15285 Alton Parkway Suite 200 Irvine, California 92618
Re: K163142
Trade/Device Name: Speedstitch Suture Passer; Speedstitch Suture Cartridges, White Suture, Blue Cobraid, Black Cobraid, Mixed Pack; Speedstitch Needle Loader And Unloader Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable Poly(Ethylene Terephthalate) Surgical Suture Regulatory Class: Class II Product Code: GAT, NBH, HXK Dated: November 7, 2016 Received: November 9, 2016
Dear Ms. Kasperowicz:
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 (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. 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.
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
SpeedStitch Suture Passer System
Indications for Use (Describe)
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
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)
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3
November 7, 2016
510(k) Summary
ArthroCare® Corporation
SpeedStitch® System
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
General Information
| Submitter Name: | ArthroCare Corporation, a Smith & Nephew Company |
|---|---|
| Address: | 15285 Alton Parkway, Suite 200 |
| Irvine, CA. 92618 | |
| Contact Person: | Laura Kasperowicz |
| Principle Regulatory Affairs Specialist | |
| Phone: 949-585-2406 | |
| Fax: 949-585-2401 | |
| Date Prepared: | November 7, 2016 |
Device System Names/Components
The SpeedStitch System is a Class II device consisting of the following components:
| Proprietary: | SpeedStitch Suture Passer |
|---|---|
| Common: Suture Passer | |
| Classification: Class I | |
| Product Code: NBH | |
| CFR Section: 21 CFR 888.1100 | |
| Proprietary: | SpeedStitch Needle Cassette |
| Common: Holder, Needle, Orthopedic | |
| Classification: Class I | |
| Product Code: HXK | |
| CFR Section: 21 CFR 888.4540 | |
| Proprietary: | Suture Cartridge containing MagnumWire® Suture |
| Common: Suture, Nonabsorbable, Synthetic, Polyethylene | |
| Classification: Class II | |
| Product Code: GAT | |
| CFR Section: 21 CFR 878.5000 |
Predicate Device
The SpeedStitch System is substantially equivalent to the following:
4
Description
The SpeedStitch System is an orthopedic/arthroscopic instrument for mechanically delivering sutures through soft tissue based on the basic design concepts of handheld, manual suture passers.
The handle is provided non-sterile. The needle cassette and suture cartridge are sterilized by ethylene oxide. The finished products are packaged in a Tyvek® pouch inserted into a chipboard carton.
Intended Use/Indications For Use
The SpeedStitch System is indicated for use in the placement of suture(s) through soft tissue in arthroscopic and limited access procedures.
Non-Clinical Data
Bench testing was performed on both the proposed and predicate devices. This in vitro testing involved grasping of a tissue model with the suture passer, insertion of needles through the tissue model and capturing suture from suture cartridges, which was successfully pulled through the tissue model using the suture passer. Design Verification testing was performed in order to verify the design outputs meet the design inputs. Simulated use testing was performed on the device and accessory devices (suture cartridges) which will be promoted for use with the SpeedStitch system in order to affirm safety and effectiveness.
The test results demonstrate that the proposed SpeedStitch meets its design, performance, and safety specifications. Based on the test results, the proposed device performs as intended and mechanical properties are substantially equivalent to the predicate device when used in accordance with labeling.
Clinical Data
No clinical or animal data are included in this submission.
Summary
All testing demonstrates that the proposed SpeedStitch performs as intended and has acceptable performance when used in accordance with the labeling.
As the intended use, operating principle, materials and technological characteristics are comparable to the predicate device, the proposed SpeedStitch System is substantially equivalent. The minor differences between the proposed SpeedStitch System and predicate device do not raise any new questions of safety or effectiveness.
5
ArthroCare® Corporation Premarket Notification
SPEEDSTITCH® SYSTEM
November 7, 2016
| Comparison of Device Characteristics | |||
|---|---|---|---|
| Parameter | M-Connector Ultra | ||
| Predicate Device | SpeedStitch | ||
| Predicate Device | SpeedStitch | ||
| Proposed Device | |||
| 510(k) | K121306 | K042031 | TBD |
| Panel | General & Plastic Surgery, | ||
| Orthopedic | Same | Same | |
| Product Code(s) | GAT & NBH | GAT | GAT/NBH/HXK |
| Classification Section | 878.5000 | ||
| 888.1100 | 878.5000 | 878.5000 | |
| 888.1100 | |||
| 888.4540 | |||
| Classification Name | > Suture, Nonabsorbable, | ||
| Synthetic, Polyethylene |
Arthroscope & Accessories
(Suture Passer) | > Suture, Nonabsorbable,
Synthetic, Polyethylene | > Suture, Nonabsorbable,
Synthetic, Polyethylene
Arthroscope & Accessories
(Suture Passer)
Holder, Needle, Orthopedic |
| Device Classification | Class II (Sutures) &
Class I (Handle, Connector) | Class II | Class II (Sutures),
Class I (Handle),
Class I (Needle Holder) |
| Intended Use | For use in the placement of
suture(s) through soft tissue in
arthroscopic and limited access
procedures. | For use in the placement of
suture(s) through soft tissue in
endoscopic and limited access
procedures. | For use in the placement of
suture(s) through soft tissue in
arthroscopic and limited access
procedures. |
| Design Technology | Suture Passer with 2 needles | Suture Passer with 1 needle | Suture Passer with 1 needle |
| Suture Delivery
Method | Suture preloaded in a cartridge
for arthroscopic or limited
access delivery | Same | Same |
| Suture Specifications | USP #2 Nonabsorbable
Synthetic Suture,
Polyethylene | Same | Same |
| Suture Placement | Interrupted Mattress Stitch | Simple Stitch | Simple Stitch |
| Main Components | ■ Handle
■ Connector
■ Suture Cartridge with
suture | ■ Handle with Connector
■ Suture Cartridge with
suture
■ Needle Loader & Needle
Extractor | ■ Handle with Connector
■ Suture Cartridge with
suture
■ Needle Loader & Needle
Extractor |
| Main Materials | 300/301/304/316 Stainless Steel
17-4/17-7/455 Stainless Steel
Polycarbonate
Glass Filled Nylon
UV Adhesive | Same | Same |