(268 days)
21 CFR Part 878, Docket No. 94P-0347
No
The description focuses on the mechanical function of the device for suture delivery and needle disposal, with no mention of AI or ML capabilities.
No.
A therapeutic device is one that treats or prevents a disease or condition. The StitchKit® device is a tool to facilitate suture delivery and disposal during surgery, and the suture it contains is used for soft tissue approximation, which is a surgical repair rather than a therapeutic treatment by the device itself.
No
The StitchKit® device is a surgical tool that delivers suture and stores used needles during robotic surgery. It does not analyze patient data or provide medical diagnoses.
No
The device description explicitly details a physical, sterile, single-use plastic canister containing suture and a compartment for used needles. The performance studies also focus on physical characteristics and material properties, not software validation.
Based on the provided information, the StitchKit® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used during surgery to facilitate the delivery of suture and removal of needles. This is a surgical tool, not a device used to examine specimens in vitro (outside of the body) to provide diagnostic information.
- Device Description: The description details a physical device for handling suture and needles within the surgical field. It does not mention any components or functions related to analyzing biological samples.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the device and suture (biocompatibility, shelf-life, strength, etc.), which are typical for surgical instruments and materials, not IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, providing diagnostic results, or any of the typical characteristics associated with in vitro diagnostics.
In summary, the StitchKit® is a surgical accessory designed to aid in the process of suturing during robotic surgery. It does not perform any diagnostic function by examining samples outside of the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NBY, GCJ, NAY
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
§ 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.
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Revised 510(k) Summary
| Date Prepared: | Revised September 4, 2013 |
|---|---|
| Device Trade Name: | StitchKit® |
| Common Name: | Suture Delivery Canister |
| Submitter: | Origami Surgical, LLC |
| 61 Garfield, Ave. | |
| Madison, NJ 07940 | |
| Contact Person: | John Gillespie (consultant) |
| Phone: (774) 567-0277 | |
| Email: igillespie@clovermedical.com | |
| Classification: | Class: II |
| Panel: General and Plastic Surgery | |
| SEP 0 5 2013 | |
| Regulation: 878.5035 Suture, Surgical, Nonabsorbable, | |
| Expanded, Polytetraflouroethylene | |
| Product Code: NBY, GCJ, NAY | |
| Intended Use: | 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. |
Description of Device
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