(58 days)
No
The description focuses on the mechanical function of the device (suture delivery and needle retrieval) and does not mention any AI/ML capabilities. The performance studies listed are also related to material properties and usability, not algorithmic performance.
No.
The device facilitates robotic surgery by transporting suture and removing needles, but it does not directly treat a disease or condition. The sutures it handles are therapeutic, but the device itself is a delivery and disposal system.
No.
The device's intended use is to facilitate minimally invasive robotic surgery by transporting suture and removing used needles, which are actions related to surgical intervention, not diagnosing a condition.
No
The device description clearly states "StitchKit® is a suture delivery canister," which is a physical hardware component. The performance studies also focus on physical properties like tensile strength and needle pull-off.
Based on the provided information, the StitchKit® device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of the StitchKit® is to facilitate minimally invasive robotic surgery by transporting suture and removing needles. This is a surgical tool used during a procedure on a patient.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health status. The StitchKit® does not perform this function.
- Device Description: The description confirms it's a suture delivery canister for surgical use.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, the StitchKit® falls under the category of a surgical device, not an In Vitro Diagnostic.
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.
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.
Product codes
NBY, GCJ, NAY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following tests were performed to support the changes described:
- Suture tensile strength
- Needle Pull-Off
- Suture diameter
- Suture strand length
- LAL Pyrogen
- Material Mediated Pyrogen
- Usability Evaluation
- Comparative Physico-Chemical Extraction
- Real-time Age
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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4. Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ 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:
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Food and Drug Administration
Office of Chief Information Officer
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"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 |
|---|---|
| ---------------------- | ------------- |
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5. 510(k) Summarv
| Submitter: | Origami Surgical LLC, 42 Main Street, Suite A, Madison, NJ 07940
Phone: 1-973-765-6256, Fax Number: 1-973-695-1045
Registration Number: 3010860245 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie, info@stitchkit.com |
| Date of Preparation: | May 13, 2019 |
| Device Trade Name: | StitchKit® |
| Common Name: | Suture Delivery Canister |
| Classification: | Class: II; Panel: General and Plastic Surgery
Regulation (Primary): 878.5035 Nonabsorbable Expanded,
Polytetrafluoroethylene Surgical Suture.
Product code NBY; Secondary Codes: GCJ and NAY |
| Predicate Devices: | K123811 StitchKit® Suture Delivery Canister
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.