(134 days)
Not Found
No
The device description and performance studies focus on the mechanical function of a suture delivery canister and the properties of the included sutures. There is no mention of AI or ML in the text.
No.
The device (StitchKit®) facilitates suture delivery and needle removal during robotic surgery. The sutures themselves (V-Loc™ or Quill™) are absorbable wound closure devices used for soft tissue approximation, which indicates a therapeutic function, but the question asks about the StitchKit® device.
No
This device is a suture delivery canister used in robotic surgery to transport sutures and retrieve needles. Its function is to facilitate the surgical procedure, not to diagnose medical conditions.
No
The device description clearly outlines a physical, sterile suture delivery canister with specific dimensions and components (suture strands, needles, retrieval string). The performance studies focus on physical and biological properties of the device and its contents, not software validation.
Based on the provided text, the StitchKit® Suture Delivery Canister is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to facilitate minimally invasive robotic surgery by transporting suture and removing used needles. This is a surgical tool used during a procedure on a patient.
- Device Description: The description details a physical canister for handling sutures and needles during surgery.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body) to provide information about a patient's health, diagnose conditions, or monitor treatment. The performance studies focus on the physical and biological properties of the suture and the canister's function in delivering and retrieving them.
IVD devices are typically used for tests performed on samples like blood, urine, or tissue to detect diseases, infections, or other health indicators. The StitchKit®'s function is entirely within the surgical process on the patient's body.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GAM, NEW, 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. 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 Methods
- StitchKit® V-Loc™180: Contains Covidien V-Loc™180 Wound Closure Devices
- StitchKit® Quill™ PDO: Contains Quill™ PDO Synthetic Absorbable Barbed Sutures
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
minimally invasive robotic surgery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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,
- diameter
- needle attachment
- Comparative in-vitro simulated biodegradation testing
- Stability Evaluations
- ETO Residuals
- LAL Pyrogen testing
- Comparative Physico-Chemical analysis
- Material Mediated Rabbit Pyrogen testing
- 2 Week Implantation study, followed by Histopathology testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K123811, K100257, K091087, K051609
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.
(a)
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.(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). 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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. | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 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) | Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| 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: | | | |
| Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | | | |
| "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
PSC Publishing Services (301) 443-6740 EF | | |
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5. 510(k) Summary
| Submitter: | Origami Surgical, LLC
42 Main Street, Suite A
Madison, NJ 07940
Phone: 1-973-765-6256
Fax Number: 1-973-695-1045
Email: info@stitchkit.com |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | John Gillespie (Consultant)
Phone: 1-973-765-6256
Fax Number: 1-973-695-1045
Email: info@stitchkit.com |
| Date of Preparation:
Date updated: | December 18, 2017
March 5, 2018 |
| Device Trade Name: | StitchKit® V-Loc™ 90
StitchKit® V-Loc™ 180
StitchKit® Quill™ PDO |
| Common Name: | Suture Delivery Canister |
| Classification: | Class: II
Panel: General and Plastic Surgery
Product Code (Primary): GAM, 21 CFR 878.4493
(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.