StitchKit

K191317 · Origami Surgical · NBY · Jul 12, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191317
• Device Name: StitchKit
• Applicant: Origami Surgical
• Product Code: NBY · General, Plastic Surgery
• Decision Date: Jul 12, 2019
• 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. Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.

Device Story

StitchKit® is a suture delivery canister for endoscopic robotic surgery; introduces multiple suture strands to operative field; enables safe retrieval of used needles. Device used in OR by surgeons. Facilitates minimally invasive procedures by streamlining suture management. Changes from predicate include alternate suture source, stainless steel needle finish, and extended shelf life.

Clinical Evidence

Bench testing only. Testing included suture tensile strength, needle pull-off, suture diameter/length, LAL and material-mediated pyrogen testing, comparative physico-chemical extraction, usability evaluation, and real-time aging studies.

Technological Characteristics

Suture delivery canister; contains Monotex® PTFE surgical suture and stainless steel needles. Single-use, sterile. Mechanical delivery system for robotic surgery. No software or electronic components.

Indications for Use

Indicated for general soft tissue approximation and/or ligation in cardiovascular, dental, general surgical procedures, and dura mater repair. Contraindicated for microsurgery, ophthalmic procedures, and peripheral neural tissues.

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

• StitchKit® Suture Delivery Canister (K123811)
• Riverpoint Medical Monotex® PTFE Suture (K140415)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.

July 12, 2019

Origami Surgical Mr. John Gillespie Management Representative 42 Main St. Suite A Madison, New Jersey 07940

Re: K191317

Trade/Device Name: StitchKit® Regulation Number: 21 CFR 878.5035 Regulation Name: Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture Regulatory Class: Class II Product Code: NBY, GCJ, NAY Dated: May 13, 2019 Received: May 15, 2019

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. 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.

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

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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Nina Mezu-Nwaba. PharmD., MPH., MSc. CAPT., United States Public Health Service Assistant Director (Acting), Plastic Surgery Implant Devices Team Division of Infection Control and Plastic Surgery Devices Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality 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. |
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|

**Indications for Use**

| 510(k) Number (if known) | K191317 |
|--------------------------|--------------------------------------------------------------|
| Device Name | StitchKit® Suture Deliver Canister with PTFE Surgical Suture |

**Indications for Use (Describe)**
The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and
removing used needles after suturing.

Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including
cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not
indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is
provided sterile as a single use device.

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

| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> 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

Food and Drug Administration

Office of Chief Information Officer

Paperwork Reduction Act (PRA) Staff

[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 |
|----------------------|-------------|
|----------------------|-------------|

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

# 5. 510(k) Summarv

| Submitter: | Origami Surgical LLC, 42 Main Street, Suite A, Madison, NJ 07940<br>Phone: [phone], Fax Number: 1-973-695-1045<br>Registration Number: 3010860245 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie, [e-mail] |
| Date of Preparation: | May 13, 2019 |
| Device Trade Name: | StitchKit® |
| Common Name: | Suture Delivery Canister |
| Classification: | Class: II; Panel: General and Plastic Surgery<br>Regulation (Primary): 878.5035 Nonabsorbable Expanded,<br>Polytetrafluoroethylene Surgical Suture.<br>Product code NBY; Secondary Codes: GCJ and NAY |
| Predicate Devices: | K123811 StitchKit® Suture Delivery Canister<br>K140415 Riverpoint Medical Monotex® PTFE Suture |

Device Description: 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.

#### Indication for Use:

The StitchKit® device facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing.

Monotex® PTFE surgical suture is indicated for use in general soft tissue approximation and/or ligation, including cardiovascular, dental, general surgical procedures and repair of the dura mater. Monotex® PTFE sutures are not indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissues. Monotex® PTFE suture is provided sterile as a single use device.

#### Description of Change:

This submission is related to a change to this existing legally marketed device. The differences between the original and changed device are: (1) alternate source for suture; (2) the choice of finish on stainless steel needle; and (3) longer shelf life based on realtime age testing. The Indication for Use for the StitchKit device incorporates the cleared Indication for use for the suture contained within. Hence the indication for use has been modified to align with that of the suture contained within.

These differences do not raise questions of safety or effectiveness.

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

## Performance Data:

The following tests were performed to support the changes described:

| 1. Suture tensile strength | 5. LAL Pyrogen | 9. Real-time Age |
|----------------------------|--------------------------------------------|------------------|
| 2. Needle Pull-Off | 6. Material Mediated Pyrogen | |
| 3. Suture diameter | 7. Usability Evaluation | |
| 4. Suture strand length | 8. Comparative Physico-Chemical Extraction | |

### Summary of Substantial Equivalence:

Based on the comparison to predicate and on test results we conclude the changes do not raise new questions of safety and efficacy, and that the changed device is substantially equivalent to its predicate, the original, unchanged device.