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 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® 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. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.

AI/ML Overview

The provided document is a 510(k) summary for the StitchKit® Suture Delivery Canister, which is a Class II medical device. This document details the device's indications for use, technological characteristics, and substantiates its substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria in the typical sense of a human-in-the-loop AI effectiveness study.

The device itself is a delivery system for existing sutures and not an AI-powered diagnostic or assistive device. Therefore, many of the requested criteria related to AI performance, AI effect size on human readers, expert ground truth, and training data are not applicable to this submission.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the StitchKit® are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data provided focuses on the physical and chemical properties of the device and its included sutures.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Compliance
Technological Characteristics	- Canister is legally marketed and unchanged. - Sutures are legally marketed and have not been modified, only trimmed to length and packaged within the StitchKit® canister.	- Canister is confirmed to be legally marketed and unchanged. - Sutures are confirmed to be legally marketed, not modified other than trimming and packaging for the StitchKit®.
Performance Testing	- Comparative Physico-Chemical analysis - LAL Pyrogen testing - Material Mediated Pyrogen testing - Stability Evaluations (including USP suture tensile strength, diameter, and needle attachment testing) - Comparative in-vitro simulated biodegradation testing for absorbable sutures	- Testing performed to verify substantial equivalence to predicate devices. - Specific results or thresholds are not provided in this summary, but the conclusion states that the device "has been shown to be substantially equivalent to its predicate devices" based on this data.
Indications for Use	- Facilitates minimally invasive robotic surgery by transporting suture and removing used needles. - Suture intended for soft tissue approximation where use of specific absorbable/non-absorbable sutures is appropriate.	- The device's design directly supports these indications. No performance metrics are given here for success rate of needle removal or ease of transport, rather it's implicit in its design that it fulfills these functions.

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

The document does not specify a "test set" in the context of an AI study. Instead, it refers to various forms of performance testing on the device and its components. The document doesn't provide specific sample sizes for these tests (e.g., number of sutures tested for tensile strength or number of canisters tested for pyrogenicity). The provenance of the data (e.g., country of origin, retrospective/prospective) is also not specified, as this type of information is typically not included in a 510(k) summary for a physical device.

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

Not applicable. As this is not an AI or diagnostic device, there is no "ground truth" established by experts in the context of image interpretation or clinical diagnosis. The performance criteria are based on objective physical/chemical tests.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

Not applicable. As there are no expert interpretations or subjective assessments requiring adjudication, no such method was used.

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. The StitchKit® is a physical surgical delivery device and does not involve AI or human readers for diagnostic assistance. Therefore, an MRMC study and AI effect size are irrelevant.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance validation is based on established engineering and material science standards (e.g., USP standards for suture properties, LAL pyrogen testing standards, physicochemical analysis). It's not clinical "ground truth" derived from patient outcomes or expert consensus on a diagnosis.

8. The Sample Size for the Training Set

Not applicable. There is no AI component requiring a training set.

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

Not applicable. There is no AI component requiring a training set and associated ground truth.

Summary

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July 16, 2021

Origami Surgical Inc. John Gillespie Management Representative 42 Main St. Madison, New Jersey 07940

Re: K211792

Trade/Device Name: StitchKit Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: June 9, 2021 Received: June 10, 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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,

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

Enclosure

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Indications for Use

510(k) Number (if known) K211792

Device Name StitchKit®

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) Summarv

Manufacturer:	Origami Surgical Inc.,42 Main Street, Suite A, Madison, NJ 07940Phone: 1-973-765-6256, Fax Number: 1-973-695-1045Registration Number: 3010860245
Contact Person:	John Gillespie: jgillespie@origamisurgical.com
Date of Preparation:	June 9, 2021
Trade/Device Name:	StitchKit® additional sutures
Common Name:	Suture Delivery Canister
Classification:	Class: IIPanel: General and Plastic SurgeryProduct Code: GAM (Primary), GAT, GCJ and NAY
Regulation Number:	21 CFR 878.4493
Regulation Name:	Absorbable Poly(Glycolide/L-Lactide) Surgical Suture

Devices to Which the Device is Substantially Equivalent [product code]:

K202950: StitchKit® COMBO, [GAM (Primary), GAP, GCJ and NAY] .
K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];
K990951: Maxon™ Monofilament Absorbable Sutures, [GAM]: ●
K103052: V-Loc™ PBT Non-Absorbable Wound Closure Device, [GAT];
K930591: Ti-Cron™ Braided Polyester Sutures, [GAT]. .

Device Description:

Indications for Use Statement:

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Technoloqical Characteristics:

With regard to Technological Characteristics, the StitchKit® canister with additional sutures is substantially equivalent to the predicates in that:

The canister is legally marketed and unchanged. ●
The sutures are legally marketed and have not been modified. They are only ● trimmed to length, if needed, and packaged within the StitchKit(R) 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:

Comparative Physico-Chemical analysis ●
LAL Pyrogen testing ●
Material Mediated Pyrogen testing ●
Stability Evaluations including USP suture tensile strength, diameter, and needle ● attachment testing
Comparative in-vitro simulated biodegradation testing for the absorbable sutures

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.