(36 days)
Not Found
No
The device description and performance studies focus on the mechanical function of suture delivery and needle disposal, with no mention of AI or ML capabilities.
No
The device is a suture delivery and retrieval system for robotic surgery, facilitating the use of sutures, but it does not directly treat or diagnose a disease or condition. The sutures contained within it are therapeutic devices, but the StitchKit itself is a delivery mechanism.
No
The device is a suture delivery and retrieval system used during robotic surgery. Its function is to transport suture and remove used needles, which are interventional and procedural tasks, not diagnostic.
No
The device description clearly describes a physical, sterile canister designed to transport and manage sutures and needles during robotic surgery. It does not mention any software components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- StitchKit® Function: The StitchKit® is a surgical tool designed to deliver suture material and manage used needles during minimally invasive robotic surgery. It is used directly on the patient's soft tissue during a surgical procedure.
- Lack of Specimen Analysis: The description does not mention any analysis of biological specimens or providing diagnostic information based on such analysis.
The device is a surgical instrument used in vivo (within the living body) during a surgical procedure, not an in vitro diagnostic test performed on specimens outside the 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 contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
Product codes
GAM, GAT, GCJ, NAY
Device Description
StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different 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 disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.
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
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 (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:
- Comparative Physico-Chemical analysis
- LAL Pyrogen testing
- Material Mediated Pyrogen testing
- Stability Evaluations including USP suture tensile strength, diameter, and needle attachment testing
- Comparative in-vitro simulated biodegradation testing for the absorbable sutures
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K202950, K000037, K990951, K103052, K930591
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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July 16, 2021
Origami Surgical Inc. John Gillespie Management Representative 42 Main St. Madison, New Jersey 07940
Re: K211792
Trade/Device Name: StitchKit Regulation Number: 21 CFR 878.4493 Regulation Name: Absorbable Poly(Glycolide/L-Lactide) Surgical Suture Regulatory Class: Class II Product Code: GAM Dated: June 9, 2021 Received: June 10, 2021
Dear John 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.
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
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Cindy Chowdhury, Ph.D., MBA Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211792
Device Name StitchKit®
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 contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it 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) |
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3
510(k) Summarv
| Manufacturer: | Origami Surgical Inc.,
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: jgillespie@origamisurgical.com |
| Date of Preparation: | June 9, 2021 |
| Trade/Device Name: | StitchKit® additional sutures |
| Common Name: | Suture Delivery Canister |
| Classification: | Class: II
Panel: General and Plastic Surgery
Product Code: GAM (Primary), GAT, GCJ and NAY |
| Regulation Number: | 21 CFR 878.4493 |
| Regulation Name: | Absorbable Poly(Glycolide/L-Lactide) Surgical Suture |
Devices to Which the Device is Substantially Equivalent [product code]:
- K202950: StitchKit® COMBO, [GAM (Primary), GAP, GCJ and NAY] .
- K000037: Biosyn™ Monofilament Absorbable Sutures, [GAM];
- K990951: Maxon™ Monofilament Absorbable Sutures, [GAM]: ●
- K103052: V-Loc™ PBT Non-Absorbable Wound Closure Device, [GAT];
- K930591: Ti-Cron™ Braided Polyester Sutures, [GAT]. .
Device Description:
StitchKit® is a suture delivery canister which facilitates endoscopic robotic surgery by introducing multiple strands of different 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 disposal compartment within the canister for safekeeping until the entire canister is removed through the trocar using the attached retrieval string. It is supplied sterile. Each StitchKit® contains strands of existing legally-marketed Suturing Materials, cleared for use within the device.
Indications for Use Statement:
StitchKit® Suture Delivery Canister facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing. The suture contained within the device is intended for soft tissue approximation where use of the specific absorbable or non-absorbable sutures contained within it is appropriate.
4
Technoloqical Characteristics:
With regard to Technological Characteristics, the StitchKit® canister with additional sutures is substantially equivalent to the predicates in that:
- The canister is legally marketed and unchanged. ●
- The sutures are legally marketed and have not been modified. They are only ● trimmed to length, if needed, and packaged within the StitchKit(R) 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:
- Comparative Physico-Chemical analysis ●
- LAL Pyrogen testing ●
- Material Mediated Pyrogen testing ●
- Stability Evaluations including USP suture tensile strength, diameter, and needle ● attachment testing
- Comparative in-vitro simulated biodegradation testing for the absorbable sutures
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.