STITCHKIT

K123811 · Origami Surgical, LLC · NBY · Sep 5, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123811
• Device Name: STITCHKIT
• Applicant: Origami Surgical, LLC
• Product Code: NBY · General, Plastic Surgery
• Decision Date: Sep 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5035
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

StitchKit® is a sterile, single-use plastic canister for robotically assisted endoscopic surgery; pre-loaded with six strands of non-USP ePTFE suture. Device passes through ≥12 mm trocar to transport suture to operative field. Surgeon retrieves strands individually; used needles are deposited into internal compartment. Device removed with needles inside post-procedure. Facilitates suture management in robotic surgery; reduces needle handling risks. Used in OR by surgeons.

Clinical Evidence

Bench testing only. Testing included biocompatibility, shelf-life, packaging/sterilization validation, USP suture testing (knot-pull, diameter, needle attachment), suture length, physical dimensions, dispensing force, and tensile strength of components (foam, base, cover, hinge, retrieval string).

Technological Characteristics

Sterile, single-use plastic canister; pre-loaded with six 20 cm strands of non-USP ePTFE suture (0.294–0.383 mm diameter). Sized for ≥12 mm trocar. Mechanical operation; no energy source. Sterilized in plastic tray with Tyvek® lid.

Indications for Use

Indicated for soft tissue approximation in patients requiring robotic surgery, including cardiovascular surgery and dura mater repair. Recommended for procedures where reduced suture line bleeding is desired.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• LSI Solutions Suture Placement Device (K981531)

Reference Devices

• Gore-Tex® Nonabsorbable ePTFE Surgical Suture

Submission Summary (Full Text)

{0}------------------------------------------------

K123811 page

Page 1

# Revised 510(k) Summary

| Date Prepared: | Revised September 4, 2013 |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Trade Name: | StitchKit® |
| Common Name: | Suture Delivery Canister |
| Submitter: | Origami Surgical, LLC<br>61 Garfield, Ave.<br>Madison, NJ 07940 |
| Contact Person: | John Gillespie (consultant)<br>Phone: [phone]<br>Email: [e-mail] |
| Classification: | Class: II<br>Panel: General and Plastic Surgery |
| | SEP 0 5 2013<br>Regulation: 878.5035 Suture, Surgical, Nonabsorbable,<br>Expanded, Polytetraflouroethylene<br>Product Code: NBY, GCJ, NAY |
| Intended Use: | The StitchKit® device facilitates minimally invasive robotic<br>surgery by transporting suture to the operative field and<br>removing used needles after suturing. The ePTFE suture<br>contained within StitchKit® is indicated for use in all types of<br>soft tissue approximation, including use in cardiovascular<br>surgery and dura mater repair. It is recommended for use<br>where reduced suture line bleeding during cardiovascular<br>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 < dia <0.383 mm, and strand length approx. 20 cm). The device facilitates robotically assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once within the plastic canister. The surgeon can then retrieve the suture strands from the canister one at a time. The device is sized to be passed through a ≥12 mm trocar. As suturing is completed with each strand, used needles are deposited into a compartment within the StitchKit® canister. Once the surgeon has finished all suturing, the device is removed with the used needles still inside. It is supplied sterile in a plastic tray with Tvvek® lid.

{1}------------------------------------------------

K123811 Page 2/3

Page 2

### Summary of Technological Characteristics vs. Predicate

The predicates for the StitchKit® device are the LSI Solutions Suture Placement Device (K981531); and Gore-Tex® Nonabsorbable ePTFE Surgical Suture (reference 21 CFR Part 878, Docket No. 94P-0347).

The LSI Solutions Suture Placement Device is a medical device that is used to deliver suture materials to the site of an endoscopic surgery, approximate tissue, and remove used needles afterwards. The StitchKit® device has a narrower intended use than the LSI Solutions Device in that it does not contain mechanisms which accomplish the passing of needles through tissue. However, both devices deliver suture materials to the site of an endoscopic surgery, and remove used needles afterwards.

The initial version of the StitchKit® which is the subject of this submission is provided to the user preloaded with 6 strands of a commonly used nonabsorbable ePTFE surgical suture, purchased from its manufacturer. While this suture has a very broad intended use, when loaded into the StitchKif® device, it is configured to be delivered endoscopically through a surgical trocar for use in Robotic Surgery. This is a subset of the intended use for the suture in general.

The technological characteristics for the StitchKit® device are similar to the predicate LSI Solutions Suture Placement Device in that the StitchKit® is a plastic container that contains suturing materials, and this predicate device includes a plastic container containing suturing materials (its cartridge). The technological characteristics for the StitchKit® device are similar to those for the predicate Gore-Tex® Nonabsorbable ePTFE Surgical Suture in that the StitchKit® device contains nonabsorbable ePTFE surgical suture that has been purchased from its manufacturer and modified only in that it has been cut to a new length and packaged.

#### Test Data

The performance testing performed for this device includes:

- Biocompatibility �
- Shelf-life testing
- Packaging validation .
- Sterilization validation ●
- Suture testing per USP methods including knot-pull testing, diameter, and . needle attachment
- Suture length .

{2}------------------------------------------------

K123811 page 3/3

Page 3

- Device physical dimensions including weight and size �
- . Suture dispensing force
- · Tensile evaluation of the strength of key components including foam pullout, suture-holder base pull-out, and disposal compartment cover pull-out
- Retrieval string tensile strength �
- . Hinge strength

This testing has demonstrated that the StitchKit® device meets its design input requirements, including that the suture's key characteristics are unaffected by its cutting to length, packaging and sterilization.

#### Conclusion

Based on the Indication for Use, technological characteristics, test data, and comparison to its predicate device we conclude that the StitchKit® device has been shown to be substantially equivalent to its legally marketed predicate devices and is safe and effective for its intended use.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and three wavy lines below the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 5, 2013

John Gillespic Consultant Origami Surgical, LLC 61 Garfield, Avenuc Madison. New Jersey 07940

Re: K123811

Trade/Device Name: StitchKit* Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable expanded polytetralluoroethylene surgical suture Regulatory Class: Class II Product Code: NBY, GCJ, NA Y Dated: July 29, 2013 Received: August 8, 2013

Dear Mr. Gillespic:

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 10 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. 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 docs 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{4}------------------------------------------------

Page 2 - John Gillespie

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# . Mark N. Melkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

## Indications for Use

510(k) Number (if known): K123811

Device Name: StitchKit®

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.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

David Krause -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123811