StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the StitchKit® device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.

Device Description

StitchKit® COMBO is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different suturing materials to the surgical site at one time and allowing for the safe retrieval of the needles. It is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, the used needle is placed into a disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile in a foil pouch. Each StitchKit® version contains strands of existing legallymarketed Suturing Materials, cleared for use within the StitchKit®.

AI/ML Overview

This looks like a 510(k) summary for a medical device called "StitchKit® COMBO Suture Delivery Canister". Based on the provided text, the device is explicitly a suture delivery system and not an AI or imaging device, so the requested information about AI performance, ground truth, expert adjudication, etc., is not applicable.

Here's a breakdown of why the requested information cannot be provided given this document:

No AI component: The document describes a "suture delivery canister which facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing." There is no mention of artificial intelligence, machine learning, image analysis, or any diagnostic capabilities.
Physical device, not a diagnostic algorithm: The device handles physical sutures and needles. The performance data listed (knot-pull tensile testing, diameter, needle attachment, biodegradation testing, pyrogen testing, physico-chemical analysis, stability evaluations) are all related to the physical properties and safety of the surgical sutures and the delivery system itself, not to the performance of a software algorithm.

Therefore, since the device is not an AI/ML medical device, the following points from your request are not applicable and cannot be found in the provided text:

A table of acceptance criteria and the reported device performance (The "performance data" mentioned refers to physical product testing, not AI performance metrics)
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The sample size for the training set
How the ground truth for the training set was established

In summary, this document describes a traditional medical device (suture delivery system) and does not provide any information relevant to the performance or validation of an AI/ML component.

Summary

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February 23, 2021

Origami Surgical John Gillespie Management Representative 79 Haven St. Dover, Massachusetts 02030

Re: K202950

Trade/Device Name: StitchKit COMBO Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, GAP, GCJ, NAY Dated: January 18, 2021 Received: January 21, 2021

Dear John 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. 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 located 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 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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.

Cindy Chowdhury, Ph.D., M.B.A. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K202950

Device Name StitchKit® COMBO Suture Delivery Canister

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✓ Prescription Use (Part 21 CER 801 Subpart D)
Over The Counter Use (21 CER 801 Subpart C)

X Prescription Use (Part 21 CFR 801 Subpart D)

I he-Counter Use (21 CFR 801 Subpart C)

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6. 510(k) Summary (revised 2/19/21)

Manufacturer:	Origami Surgical Inc.42 Main Street, Suite A, Madison, NJ 07940Phone: 1-973-765-6256, Fax Number: 1-973-695-1045Registration Number: 301086024507940
Contact Person:	John Gillespie: jgillespie@origamisurgical.com
Date of Preparation:	August 21, 2020
Trade/Device Name:	StitchKit® COMBO
Classification:	Class: IIPanel: General and Plastic SurgeryProduct Code (Primary): GAMSecondary Codes: GAP, GCJ and NAY
Regulation Number:	21 CFR 878.4493
Regulation Name:	Absorbable Poly(Glycolide/L-Lactide) Surgical Suture

Legally Marketed Devices to Which the Device is Substantially Equivalent:

K173874: StitchKit® V-Loc™ 90, StitchKit® V-Loc™ 180, StitchKit® Quill® PDO ●
K981935: Polvsorb™ Suture ●
K980124: SofSilk™ Suture

Device Description:

StitchKit® COMBO SK-103: Polysorb®, Vloc™-180, and Vloc™-90 ●
StitchKit® COMBO SK-104: Polysorb®. SofSilk®, and Vloc™-90 .
StitchKit® COMBO SK-105: Polysorb®, and Vloc™-90 .

Figure 1, below, illustrates how each suture exits the device through a unique Exit Hole labelled to identify the suture types. In an actual COMBO device the generic labels S1 through S6 are replaced with short labels identifying the actual sutures within the device.

Image /page/3/Figure/13 description: The image shows a diagram of an electrical component with several labeled connection points. The connection points are labeled S1, S2, S3, S4, S5, and S6. The diagram shows how the connection points are wired together.

Figure 1 StitchKit® COMBO™ in its open configuration, showing suture labels

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Indications for Use Statement:

Technological Characteristics:

With regard to Technological Characteristics, the subject StitchKit® versions are substantially equivalent to the predicate in that:

The canister portion consists of the actual predicate canister portion.
The implantable portions consist of the actual predicate wound closure materials ● as supplied by their respective manufacturers. They have not been modified, just packaged within the StitchKit® canister.

Performance Data

Performance testing has been performed in support of the intended use of these devices. This testing verifies that the subject StitchKit® versions are substantially equivalent to the predicate devices. The test data includes:

Suture functional testing including
- knot-pull tensile testing, .
- . diameter
- . needle attachment
Comparative in-vitro simulated biodegradation testing
Stability Evaluations ●
LAL Pyrogen testing ●
Comparative Physico-Chemical analysis
Material Mediated Rabbit Pyrogen testing

Conclusion:

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.

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved 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.