StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO

K173874 · Origami Surgical, LLC · GAM · May 4, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K173874
• Device Name: StitchKit V-Loc 90, StitchKit V-Loc 180, StitchKit Quill PDO
• Applicant: Origami Surgical, LLC
• Product Code: GAM · General, Plastic Surgery
• Decision Date: May 4, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4493
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.

Device Story

StitchKit® is a suture delivery canister designed for minimally invasive robotic surgery; facilitates transport of multiple suture strands to operative field; provides safe retrieval of used needles. Device sized for passage through ≥12 mm trocar. During surgery, surgeon uses suture strands; after use, needles are placed into internal compartments for safekeeping. Entire canister removed via attached retrieval string after procedure. Device contains pre-existing, legally-marketed absorbable sutures (V-Loc 90, V-Loc 180, or Quill PDO). Benefits include improved efficiency in robotic suturing workflows and enhanced safety by securing used needles for removal, reducing risk of retained foreign objects.

Clinical Evidence

Bench testing and animal study. Bench testing: knot-pull tensile strength, diameter, needle attachment, in-vitro simulated biodegradation, stability, ETO residuals, LAL pyrogen, and comparative physico-chemical analysis. Animal study: 2-week implantation study with histopathology and material-mediated rabbit pyrogen testing.

Technological Characteristics

Suture delivery canister for robotic surgery; compatible with ≥12 mm trocars. Contains unmodified, commercially available absorbable sutures (V-Loc 90, V-Loc 180, Quill PDO). Supplied sterile in foil pouch. No electronic components or software.

Indications for Use

Indicated for soft tissue approximation in patients requiring absorbable suture during minimally invasive robotic surgery.

Regulatory Classification

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.

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 (K123811)
• V-Loc™ 90 Absorbable Wound Closure Device (K100257)
• V-Loc™ 180 Absorbable Wound Closure Device (K091087)
• Quill™ Synthetic Absorbable Polydioxanone Barbed Suture (K051609)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.

May 4, 2018

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

Re: K173874

Trade/Device Name: StitchKit® V-Loc 90, StitchKit® V-Loc 180, StitchKit® Quill PDO Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM, NEW, GCJ, NAY Dated: December 18, 2017 Received: December 21, 2017

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 CFR Part 807); labeling (21 CFR Part 801); medical device 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);

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

#### Page 2 - Mr. John Gillespie

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# David Krause -S

for 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

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

## 4. Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120<br>Expiration Date: 06/30/2020<br>See PRA Statement below. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number (if known) | K173874 | | |
| Device Name | StitchKit® V-Loc ^TM 90, StitchKit® V-Loc ^TM 180, StitchKit® Quill ^TM PDO | | |
| 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 within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate. | | |
| Type of Use (Select one or both, as applicable) | <table style="border:none;"><tr><td style="border:none;"><input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</td><td style="border:none;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</td></tr></table> | <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | | | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | | | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>[e-mail] | | | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | | |
| FORM FDA 3881 (7/17) | Page 1 of 1<br>PSC Publishing Services [phone] EF | | |

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

### 5. 510(k) Summary

| Submitter: | Origami Surgical, LLC<br>42 Main Street, Suite A<br>Madison, NJ 07940<br>Phone: [phone]<br>Fax Number: 1-973-695-1045<br>Email: [e-mail] |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie (Consultant)<br>Phone: [phone]<br>Fax Number: 1-973-695-1045<br>Email: [e-mail] |
| Date of Preparation:<br>Date updated: | December 18, 2017<br>March 5, 2018 |
| Device Trade Name: | StitchKit® V-Loc™ 90<br>StitchKit® V-Loc™ 180<br>StitchKit® Quill™ PDO |
| Common Name: | Suture Delivery Canister |
| Classification: | Class: II<br>Panel: General and Plastic Surgery<br>Product Code (Primary): GAM, 21 CFR 878.4493<br>(Secondary): NEW, GCJ and NAY |

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

- K123811: StitchKit® Suture Delivery Canister with . ePTFE Surgical Suture
- . K100257: V-Loc™ 90 Absorbable Wound Closure Device
- . K091087: V-Loc™ 180 Absorbable Wound Closure Device
- . K051609: Quill™ Synthetic Absorbable Polydioxanone Barbed Suture.

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

#### Description of Device

StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of 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 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 legally-marketed Suturing Materials. The subject StitchKit® versions contain:

- StitchKit® V-Loc™90: Contains Covidien V-Loc™90 Wound Closure -Devices
- -StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices
- -StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures

#### Intended 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 within this StitchKit® device is intended for soft tissue approximation where use of an absorbable suture is appropriate.

#### Technoloqical Characteristics:

With regard to Technological Characteristics, the subject StitchKit® versions are substantially equivalent to the predicates 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, o
- o diameter
- needle attachment o
- Comparative in-vitro simulated biodegradation testing ●
- Stability Evaluations ●
- ETO Residuals ●

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

- LAL Pyrogen testing ●
- Comparative Physico-Chemical analysis ●
- Material Mediated Rabbit Pyrogen testing ●
- 2 Week Implantation study, followed by Histopathology 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.