StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

Device Description

The StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture ("StitchKit") is a sterile, single-use plastic canister that is pre-loaded with multiple strands of legally marketed monofilament polypropylene surgical suture (with needles attached). The device facilitates robotic-assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once. The surgeon can then dispense the suture strands one at a time. The device is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, used needles are deposited into a compartment within the StitchKit® canister. Once the surgeon has finished suturing, the device is removed along with the used needles inside. It is supplied sterile in a plastic tray with Tyvek® lid.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture). It describes the device, its intended use, and its substantial equivalence to predicate devices based on performance data. Importantly, this document is for a physical medical device (a suture delivery system), not an AI/ML algorithm or software device. Therefore, many of the requested fields regarding AI/ML study design are not applicable.

Here's the information that can be extracted or stated as not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Suture Testing:
USP knopull testing	Performed (details not provided beyond "suture testing performed")
Diameter	Performed (details not provided beyond "suture testing performed")
Needle attachment	Performed (details not provided beyond "suture testing performed")
Mechanical Testing:
Suture dispensing force testing	Performed (details not provided)
Shelf life testing	Performed (details not provided)
Biocompatibility:
Physicochemical extraction testing	Performed (details not provided)
LAL Pyrogen testing	Performed (details not provided)
Sterilization:
Sterilization included in original 510(k), K123811	Proposed device included in original sterilization validation, no changes.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: The document does not specify exact sample sizes for the various tests. It generally states that "performance testing was performed."
Data Provenance: Not explicitly stated, but typically such testing is conducted in a controlled lab environment by the manufacturer. The document does not mention human patient data for testing device performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. This device is a physical suture delivery system. Its performance is evaluated through engineering and biocompatibility tests, not by expert interpretation of data or images. Ground truth as typically understood in AI/ML validation (e.g., expert consensus on medical images) does not apply.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. See explanation above. The performance tests are objective engineering and biological assessments.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is a physical medical device, not an AI/ML diagnostic or assistive tool. No human reader studies with or without AI assistance were conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical medical device, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Ground Truth for Physical Device Testing: The "ground truth" for this device's performance tests would be established by:
- Validated Test Methods: Adherence to recognized standards (e.g., USP for suture properties).
- Objective Measurements: Quantitative measurements of physical properties (knopull strength, diameter, dispensing force, shelf life parameters) and biological responses (pyrogenicity, extraction levels).
- Predicate Device Performance: Comparison to the known performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. No training set exists for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are 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

December 16, 2014

Origami Surgical, LLC % Mr. John Gillespie Clover Medical, LLC 79 Haven Street Dover, Massachusetts 02030

Re: K142639

Trade/Device Name: StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, GCJ, NAY Dated: September 22, 2014 Received: September 23, 2014

Dear Mr. Gillespie:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

for

Sincerely yours,

David Krause -S

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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Indications for Use

510(k) Number (if known) K142639

Device Name

StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture

Indications for Use (Describe)

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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510(k) Summary

Submitter: Origami Surgical, LLC

42 Main Street, Suite A

Madison, NJ 07940

Phone: 1-973-765-6256

Fax Number: 1-973-695-1045

Email: origamisurgical@gmail.com

Contact Person: John Gillespie (consultant)

Phone: 1-973-765-6256

Fax Number: 1-973-695-1045

Email: origamisurgical@gmail.com

Date of Preparation: September 15, 2014

Device Trade Name: StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture

Common Name: Suture Delivery Canister containing suture, non-absorbable, synthetic, Polypropylene

Classification: Class: II

Panel: General and Plastic Surgery

Regulation: 876.1500 Endoscopes & Accessories

Product Code: GCJ Lap'scope, Gen'l & Plastic Surgery

Regulation: 876.1500 Endoscope and Accessories

Product Code: NAY (System, Surgical, Computer Controlled Instrument)

Regulation: 878.5010 Nonabsorbable polypropylene surgical suture

Product Code: GAW Nonabsorbable polypropylene surgical suture.

Legally Marketed Devices to Which the Device is Substantially Equivalent:

K123811: StitchKit® Suture Delivery Canister with ePTFE Surgical Suture

K133356: Prolene® Polypropylene Surgical Suture

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Description of Device:

Indications for Use:

Summary of Technological Characteristics vs. Predicate:

The only significant difference in technological characteristics versus the primary predicate is the different suture material within the device (ePTFE vs. polypropylene). The suture within the proposed device is equivalent to the second predicate, polypropylene surgical suture.

Performance Data

The performance testing performed for this device includes:

| | Suture testing including USP knopull testing, diameter, and needle attachment

□ Suture dispensing force testing

■ SheHife testing

| Physicechemical extraction testing & LAL Pyrogen testing

The predicate StitchKit® device was subjected to biocompatibility testing to support the original StitchKit® 510(k), K123811, and that testing applies to this StitchKit® version since the only change is the new legally marketed suture.

The proposed device was included in the sterilization included in the original 510(k), K123811, and there are no changes related to sterilization.

Conclusion

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Based on the Indication for Use, technological characteristics, test data, and comparison to its predicate devices we conclude that the proposed StitchKit® device has been shown to be substantially equivalent to its predicate devices and is safe and effective for its intended use.

Regulation Number and Section

§ 878.5010 Nonabsorbable polypropylene surgical suture.

(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.