The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The ePTFE suture contained within StitchKit® is indicated for use in all types of soft tissue approximation, including use in cardiovascular surgery and dura mater repair. It is recommended for use where reduced suture line bleeding during cardiovascular anastomotic procedures is desired.

Device Description

The StitchKit® device is a sterile, single-use plastic canister that is pre-loaded with six strands of non-USP ePTFE suture, (diameter approx. 0.294 mm < dia <0.383 mm, and strand length approx. 20 cm). The device facilitates robotically assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once within the plastic canister. The surgeon can then retrieve the suture strands from the canister 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 all suturing, the device is removed with the used needles still inside. It is supplied sterile in a plastic tray with Tvvek® lid.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the StitchKit® device, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the types of performance testing conducted but does not explicitly state quantitative acceptance criteria or detailed numerical results for each test. Instead, it offers a high-level summary that "This testing has demonstrated that the StitchKit® device meets its design input requirements."

Therefore, the table below will list the types of performance testing conducted and the general statement regarding their fulfillment, as specific thresholds and results are not available in this document.

Acceptance Criteria Category	Reported Device Performance
Material & Product Properties
Biocompatibility	Meets design input requirements (implied acceptable)
Shelf-life testing	Meets design input requirements (implied acceptable)
Packaging validation	Meets design input requirements (implied acceptable)
Sterilization validation	Meets design input requirements (implied acceptable)
Suture testing (USP methods)	Suture's key characteristics unaffected by cutting, packaging, sterilization; includes knot-pull, diameter, needle attachment
Suture length	Meets design input requirements (implied acceptable)
Device physical dimensions (weight, size)	Meets design input requirements (implied acceptable)
Functional Performance
Suture dispensing force	Meets design input requirements (implied acceptable)
Tensile evaluation of key components (foam pullout, suture-holder base pull-out, disposal compartment cover pull-out)	Meets design input requirements (implied acceptable)
Retrieval string tensile strength	Meets design input requirements (implied acceptable)
Hinge strength	Meets design input requirements (implied acceptable)

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes used for each performance test (e.g., number of devices tested for hinge strength, number of suture strands for knot-pull).

It also does not provide information about the country of origin of the data or whether the studies were retrospective or prospective. The nature of these tests (e.g., biocompatibility verification, mechanical testing) typically implies laboratory-based, prospective testing conducted by the manufacturer or contracted labs.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable to the StitchKit® device as described. The testing performed involves objective physical and mechanical measurements and validations (e.g., tensile strength, dimensions, sterilization efficacy, biocompatibility). These do not rely on expert interpretation in the way, for example, a diagnostic imaging study would require radiologists to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. Adjudication methods like 2+1 or 3+1 are used for subjective assessments where multiple experts might disagree, which is not the case for the physical and mechanical performance tests described for the StitchKit®.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This type of study is typically performed for diagnostic or AI-powered devices to assess the impact of the device on human reader performance, which is not relevant for this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone study was not conducted. The StitchKit® is a medical device (suture delivery canister with pre-loaded suture) that facilitates surgical procedures; it is not an algorithm or an AI-powered system that would have a "standalone performance" in the sense of an algorithm operating independently of human interaction for interpretation or decision-making. Its performance is assessed through its physical and functional attributes.

7. Type of Ground Truth Used

The "ground truth" for the StitchKit® device's performance tests is based on pre-defined design input requirements, industry standards (e.g., USP methods for suture testing), and objective physical and mechanical measurements. For example, for tensile evaluations, the ground truth would be a specific force threshold that the component must withstand, measured objectively. For suture diameter, the ground truth is the specified diameter range. For sterilization, it's the demonstration of sterility per established protocols.

8. Sample Size for the Training Set

This information is not applicable. The StitchKit® is a physical medical device (suture delivery canister and suture), not an AI/ML algorithm or software that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this device.

Summary

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K123811 page

Page 1

Revised 510(k) Summary

Date Prepared:	Revised September 4, 2013
Device Trade Name:	StitchKit®
Common Name:	Suture Delivery Canister
Submitter:	Origami Surgical, LLC61 Garfield, Ave.Madison, NJ 07940
Contact Person:	John Gillespie (consultant)Phone: (774) 567-0277Email: igillespie@clovermedical.com
Classification:	Class: IIPanel: General and Plastic Surgery
	SEP 0 5 2013Regulation: 878.5035 Suture, Surgical, Nonabsorbable,Expanded, PolytetraflouroethyleneProduct Code: NBY, GCJ, NAY
Intended Use:	The StitchKit® device facilitates minimally invasive roboticsurgery by transporting suture to the operative field andremoving used needles after suturing. The ePTFE suturecontained within StitchKit® is indicated for use in all types ofsoft tissue approximation, including use in cardiovascularsurgery and dura mater repair. It is recommended for usewhere reduced suture line bleeding during cardiovascularanastomotic procedures is desired.

Description of Device

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K123811 Page 2/3

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Summary of Technological Characteristics vs. Predicate

The predicates for the StitchKit® device are the LSI Solutions Suture Placement Device (K981531); and Gore-Tex® Nonabsorbable ePTFE Surgical Suture (reference 21 CFR Part 878, Docket No. 94P-0347).

The LSI Solutions Suture Placement Device is a medical device that is used to deliver suture materials to the site of an endoscopic surgery, approximate tissue, and remove used needles afterwards. The StitchKit® device has a narrower intended use than the LSI Solutions Device in that it does not contain mechanisms which accomplish the passing of needles through tissue. However, both devices deliver suture materials to the site of an endoscopic surgery, and remove used needles afterwards.

The initial version of the StitchKit® which is the subject of this submission is provided to the user preloaded with 6 strands of a commonly used nonabsorbable ePTFE surgical suture, purchased from its manufacturer. While this suture has a very broad intended use, when loaded into the StitchKif® device, it is configured to be delivered endoscopically through a surgical trocar for use in Robotic Surgery. This is a subset of the intended use for the suture in general.

The technological characteristics for the StitchKit® device are similar to the predicate LSI Solutions Suture Placement Device in that the StitchKit® is a plastic container that contains suturing materials, and this predicate device includes a plastic container containing suturing materials (its cartridge). The technological characteristics for the StitchKit® device are similar to those for the predicate Gore-Tex® Nonabsorbable ePTFE Surgical Suture in that the StitchKit® device contains nonabsorbable ePTFE surgical suture that has been purchased from its manufacturer and modified only in that it has been cut to a new length and packaged.

Test Data

The performance testing performed for this device includes:

Biocompatibility �
Shelf-life testing
Packaging validation .
Sterilization validation ●
Suture testing per USP methods including knot-pull testing, diameter, and . needle attachment
Suture length .

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K123811 page 3/3

Page 3

Device physical dimensions including weight and size �
. Suture dispensing force
· Tensile evaluation of the strength of key components including foam pullout, suture-holder base pull-out, and disposal compartment cover pull-out
Retrieval string tensile strength �
. Hinge strength

This testing has demonstrated that the StitchKit® device meets its design input requirements, including that the suture's key characteristics are unaffected by its cutting to length, packaging and sterilization.

Conclusion

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2013

John Gillespic Consultant Origami Surgical, LLC 61 Garfield, Avenuc Madison. New Jersey 07940

Re: K123811

Trade/Device Name: StitchKit* Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetralluoroethylene surgical suture Regulatory Class: Class II Product Code: NBY, GCJ, NA Y Dated: July 29, 2013 Received: August 8, 2013

Dear Mr. Gillespic:

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 10 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 docs 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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - John Gillespie

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 Small Manufacturers. International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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 yours,

. Mark N. Melkerson -S

Mark N. Melkerson Acting 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): K123811

Device Name: StitchKit®

Indications for Use:

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123811

Regulation Number and Section

§ 878.5035 Nonabsorbable expanded polytetrafluoroethylene surgical suture.

(a)
Identification. Nonabsorbable expanded polytetrafluoroethylene (ePTFE) surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from ePTFE and is intended for use in soft tissue approximation and ligation, including cardiovascular surgery. It may be undyed or dyed with an approved color additive and may be provided with or without an attached needle(s).(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.