StitchKit

K142639 · Origami Surgical, LLC · GAW · Dec 16, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K142639
• Device Name: StitchKit
• Applicant: Origami Surgical, LLC
• Product Code: GAW · General, Plastic Surgery
• Decision Date: Dec 16, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

Device Story

StitchKit is a sterile, single-use plastic canister pre-loaded with multiple strands of monofilament polypropylene surgical suture with needles. Designed for robotic-assisted endoscopic surgery, the device is inserted through a ≥12 mm trocar to transport multiple sutures to the operative field. Surgeons dispense sutures individually; used needles are deposited into an internal compartment within the canister. Upon completion, the device is removed from the patient, safely containing the used needles. The device streamlines suture management and needle disposal in the surgical field, reducing the need for multiple instrument exchanges.

Clinical Evidence

No clinical data. Evidence consists of bench testing including USP knot-pull testing, suture diameter, needle attachment strength, suture dispensing force, shelf-life testing, and physicochemical/LAL pyrogen testing. Biocompatibility and sterilization data were leveraged from the predicate device (K123811).

Technological Characteristics

Sterile, single-use plastic canister; pre-loaded with monofilament polypropylene surgical suture. Dimensions compatible with ≥12 mm trocars. Supplied in plastic tray with Tyvek® lid. Sterilization method unchanged from predicate K123811.

Indications for Use

Indicated for use in general soft tissue approximation and/or ligation during minimally invasive robotic surgery.

Regulatory Classification

Identification

Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and the suture may be provided with or without a standard needle attached.

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

• StitchKit® Suture Delivery Canister with ePTFE Surgical Suture (K123811)
• Prolene® Polypropylene Surgical Suture (K133356)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and a staff. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

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

December 16, 2014

Origami Surgical, LLC % Mr. John Gillespie Clover Medical, LLC 79 Haven Street Dover, Massachusetts 02030

Re: K142639

Trade/Device Name: StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture Regulation Number: 21 CFR 878.5010 Regulation Name: Nonabsorbable polypropylene surgical suture Regulatory Class: Class II Product Code: GAW, GCJ, NAY Dated: September 22, 2014 Received: September 23, 2014

Dear Mr. 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. 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

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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 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

for

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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# Indications for Use

510(k) Number (if known) K142639

#### Device Name

StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture

Indications for Use (Describe)

StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> |
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| <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### 510(k) Summary

Submitter: Origami Surgical, LLC

42 Main Street, Suite A

Madison, NJ 07940

Phone: [phone]

Fax Number: 1-973-695-1045

Email: [e-mail]

Contact Person: John Gillespie (consultant)

Phone: [phone]

Fax Number: 1-973-695-1045

Email: [e-mail]

Date of Preparation: September 15, 2014

Device Trade Name: StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture

Common Name: Suture Delivery Canister containing suture, non-absorbable, synthetic, Polypropylene

Classification: Class: II

Panel: General and Plastic Surgery

Regulation: 876.1500 Endoscopes & Accessories

Product Code: GCJ Lap'scope, Gen'l & Plastic Surgery

Regulation: 876.1500 Endoscope and Accessories

Product Code: NAY (System, Surgical, Computer Controlled Instrument)

Regulation: 878.5010 Nonabsorbable polypropylene surgical suture

Product Code: GAW Nonabsorbable polypropylene surgical suture.

#### Legally Marketed Devices to Which the Device is Substantially Equivalent:

K123811: StitchKit® Suture Delivery Canister with ePTFE Surgical Suture

K133356: Prolene® Polypropylene Surgical Suture

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### Description of Device:

The StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture ("StitchKit") is a sterile, single-use plastic canister that is pre-loaded with multiple strands of legally marketed monofilament polypropylene surgical suture (with needles attached). The device facilitates robotic-assisted endoscopic surgery by introducing these multiple strands of suture to the surgical field all at once. The surgeon can then dispense the suture strands 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 suturing, the device is removed along with the used needles inside. It is supplied sterile in a plastic tray with Tvvek® lid.

# Indications for Use:

StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. It contains polypropylene surgical suture indicated for use in general soft tissue approximation and/or ligation.

# Summary of Technological Characteristics vs. Predicate:

The only significant difference in technological characteristics versus the primary predicate is the different suture material within the device (ePTFE vs. polypropylene). The suture within the proposed device is equivalent to the second predicate, polypropylene surgical suture.

# Performance Data

The performance testing performed for this device includes:

| | Suture testing including USP knopull testing, diameter, and needle attachment

□ Suture dispensing force testing

■ SheHife testing

| Physicechemical extraction testing & LAL Pyrogen testing

The predicate StitchKit® device was subjected to biocompatibility testing to support the original StitchKit® 510(k), K123811, and that testing applies to this StitchKit® version since the only change is the new legally marketed suture.

The proposed device was included in the sterilization included in the original 510(k), K123811, and there are no changes related to sterilization.

# Conclusion

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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 and is safe and effective for its intended use.