(146 days)
No
The description focuses on the mechanical function of a suture delivery and needle disposal system. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No
The device is a suture delivery and needle disposal system for robotic surgery, not a therapeutic device that directly treats a condition or disease. The sutures it delivers perform the therapeutic function of soft tissue approximation.
No.
The device's description and intended use clearly state its function is to transport suture to the operative field and remove used needles, which are surgical assistance functions, not diagnostic ones.
No
The device description clearly describes a physical, sterile suture delivery canister with mechanical components for transporting suture and retrieving needles, not a software-only product.
Based on the provided information, the StitchKit® Suture Delivery Canister is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to facilitate minimally invasive robotic surgery by transporting suture and removing used needles. It also mentions the use of the contained suture for soft tissue approximation. This is a surgical device, not a diagnostic one.
- Device Description: The description details a mechanical device for handling sutures and needles during surgery. It does not describe any components or functions related to testing samples from the human body.
- Performance Studies: The performance studies focus on the functional aspects of the suture and the device's ability to handle them (tensile strength, diameter, needle attachment, biodegradation, stability, pyrogen testing). These are tests related to the physical and biological compatibility of a surgical implant/device, not diagnostic performance.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The StitchKit® does not perform any such function.
N/A
Intended Use / Indications 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 StitchKit® device is intended for soft tissue approximation where use of the specific absorbable sutures contained within it is appropriate.
Product codes
GAM, GAP, GCJ, NAY
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®. The subject StitchKit® versions contain:
- 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 .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a bold, sans-serif font and the full name, "U.S. Food & Drug Administration," written below it in a smaller font.
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)
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 sutures contained within it is appropriate.
| 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 07940
Phone: 1-973-765-6256, Fax Number: 1-973-695-1045
Registration Number: 301086024507940 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie: jgillespie@origamisurgical.com |
| Date of Preparation: | August 21, 2020 |
| Trade/Device Name: | StitchKit® COMBO |
| Classification: | Class: II
Panel: General and Plastic Surgery
Product Code (Primary): GAM
Secondary 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 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®. The subject StitchKit® versions contain:
- 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:
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.
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.