(90 days)
No
The description focuses on the mechanical function of delivering and storing suture and needles during robotic surgery. There is no mention of AI/ML terms, image processing, or data-driven performance metrics.
No.
The device facilitates suture delivery and needle removal during robotic surgery; the sutures themselves are for therapeutic use (tissue approximation and/or ligation), but the device itself is an accessory for the surgical procedure.
No
The device is described as a "Suture Delivery Canister" that transports and removes suture materials and used needles during robotic surgery. Its function is to facilitate surgical procedures (suturing), not to diagnose or detect medical conditions.
No
The device description clearly states it is a sterile, single-use plastic canister pre-loaded with suture and needles, which are physical components, not software.
Based on the provided information, the StitchKit® Suture Delivery Canister with Polypropylene Surgical Suture is not an IVD (In Vitro Diagnostic).
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 directly on the patient during a procedure.
- Device Description: The description details a sterile, single-use plastic canister containing surgical suture and designed for use in robotic-assisted endoscopic surgery. It's a delivery and disposal system for surgical materials.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening. The device's function is purely mechanical and procedural within the surgical setting.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic or other medical information. The StitchKit® does not fit this description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
GAW, GCJ, NAY
Device Description
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.
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
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 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.
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.
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
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
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.(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/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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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: origamisurgical@gmail.com
Contact Person: John Gillespie (consultant)
Phone: 1-973-765-6256
Fax Number: 1-973-695-1045
Email: origamisurgical@gmail.com
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
4
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
5
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.