(264 days)
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.
StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.
The provided text describes a 510(k) premarket notification for a medical device called StitchKit®. This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a minor modification related to the device's insertion and removal method (allowing use through an 8mm trocar incision in addition to a 12mm trocar).
Crucially, this document does NOT describe the acceptance criteria or a study proving the device meets performance criteria for a complex AI/ML medical device. The device in question is a suture delivery canister, a physical surgical tool, not an AI or imaging device. Therefore, many of the requested points related to AI/ML device validation (like expert adjudication, MRMC studies, ground truth for training/test sets, effect size of human reader improvement with AI assistance, and standalone AI performance) are not applicable to this submission.
The "clinical data" mentioned (retrospective case review n=422) is cited in the context of supporting the modification to the instructions for use, not for establishing the core performance of an AI algorithm. The performance data section refers to "functional performance test consisting of simulated surgical testing in an animal model" to demonstrate compatibility with the new insertion/removal technique, which is a physical device test, not an AI/ML study.
Therefore, I cannot fulfill most of your request for an AI/ML device, as the provided document pertains to a physical surgical device and its minor instruction for use modification.
However, I can extract the safety and efficacy information relevant to this device (the StitchKit® suture delivery canister) as presented in the document, acknowledging that it doesn't align with the detailed AI/ML validation questions.
Based on the provided document for the StitchKit® Suture Delivery Canister (a non-AI device):
1. A table of acceptance criteria and the reported device performance
The document does not specify formal, quantitative acceptance criteria for device performance in the typical sense of accuracy, sensitivity, or specificity, as it's a physical tool. Instead, the "performance" demonstrated relates to its functional compatibility with a new surgical technique.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compatibility with 8 mm trocar site incision insertion/removal | Demonstrated through "functional performance test consisting of simulated surgical testing in an animal model." No specific numerical performance metric provided beyond "compatible." |
| Maintenance of Substantial Equivalence to Predicate | Concluded based on: unchanged Indication for Use and Technological Characteristics, functional test data, clinical data (retrospective case review), and comparison to predicate device including risk analysis. |
| Functionality in transporting suture and removing used needles | (Presumed to be maintained from the predicate device and inherent to the device's design, as no change to core functionality is described.) |
2. Sample size used for the test set and the data provenance
- Test Set (for the modification validity):
- Sample Size: n=422 (Cited as a "retrospective case review clinical study").
- Data Provenance: Conducted by "an academic medical center." The country of origin is not specified but is implicitly in the US due to FDA submission. The study was retrospective.
- Functional Performance Test: Conducted in an "animal model." Sample size for this specific test is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a physical device, not an AI/ML diagnostic or image analysis device where "ground truth" would be established by experts interpreting medical data. The "ground truth" for the retrospective case review would likely be the surgical outcomes or successful use reported in the patient records.
4. Adjudication method for the test set
- Not Applicable. As above, no expert adjudication process is described or relevant for this type of device and study.
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. No MRMC study was done, as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. No standalone algorithm performance was evaluated, as this is not an algorithm-based device.
7. The type of ground truth used
- For the retrospective case review (n=422), the "ground truth" would be derived from clinical records and surgical outcomes related to the use of the device in actual patient cases, rather than expert interpretation of images or pathology. The document doesn't explicitly state how "success" or "performance" was quantified from these cases, but it supports the safety/effectiveness of the device, particularly with the proposed instruction modification.
- For the animal model functional test, the "ground truth" was direct observation of the device's physical handling and compatibility with the 8mm trocar site.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an machine learning model.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used.
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February 14, 2023
Origami Surgical Inc . John Gillespie Management Representative 42 Main St. Madison, New Jersey 07940
Re: K221527
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: Mav 24, 2022 Received: May 26, 2022
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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,
Image /page/1/Picture/5 description: The image shows the name "Deborah A. Fellhauer" in a large, bold font. Below the name, there is a "-S" in a smaller font. The text is black and is set against a white background. The letters "FDA" are faintly visible in the background.
Deborah Fellhauer, RN, BSN 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: 06/30/2023See PRA Statement below. |
| 510(k) Number ( if known ) | K221527 |
| Device Name | StitchKit® |
| Indications for Use ( Describe ) | 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 |
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
| Manufacturer: | K221527Origami 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 |
| Preparation Date: | February 9, 2023 |
| Trade/Device Name: | StitchKit® |
| 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:
- K211792: StitchKit®, product code GAM (Primary), GAT, GCJ and NAY .
Device Description:
StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. As suturing is completed with each strand, the used needle is placed into a compartment within the canister for safekeeping until the entire canister is removed either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.
Indication for Use:
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.
Comparison to Predicate:
This submission relates to a modification of the instructions for use of an existing device. There is no change to the Intended Use, Indications for Use Statement, nor Technological Characteristics. The proposed change is for modifications to the Instructions for Use for the device, which previously stated that the device may only be inserted or removed via a ≥ 12 mm trocar. The revised instructions add that the device may alternatively be
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inserted or removed through an existing 8 mm trocar site incision under direct endoscopic visualization by removing the trocar and placing the device through that incision into the surgical field.
This submission was also supported by a retrospective case review clinical study (n=422) conducted by an academic medical center.
Performance Data
A functional performance test consisting of simulated surgical testing in an animal model was conducted. This included insertion and removal through an 8 mm trocar site in the model to demonstrate that the technique is compatible with the StitchKit device.
Conclusion:
Based on the unchanged Indication for Use and Technological Characteristics; functional test data; clinical data; and comparison to the predicate device including risk analysis; we conclude that the proposed StitchKit® device is substantially equivalent to its predicate.
§ 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.