(264 days)
Not Found
No
The description focuses on the mechanical function of the device for suture delivery and needle retrieval during robotic surgery. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a delivery system for sutures and needles used in surgery, facilitating the surgical procedure rather than directly treating a disease or condition itself.
No
The device is described as facilitating suture delivery and needle removal during robotic surgery. Its intended use is for soft tissue approximation, not for diagnosing medical conditions or diseases.
No
The device description clearly states it is a sterile, single-use plastic canister with pre-loaded suturing materials and needles, indicating it is a physical hardware device.
Based on the provided information, the StitchKit® Suture Delivery Canister is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device "facilitates minimally invasive robotic surgery by transporting suture to the operative field and removing used needles after suturing." It is used during a surgical procedure to deliver and manage surgical materials.
- Device Description: The description details a sterile, single-use plastic canister containing sutures and needles, designed for use in endoscopic robotic surgery. It describes its function in handling surgical materials and needles.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are typically used to test samples like blood, urine, tissue, etc., to provide diagnostic or other health-related information. The StitchKit® is a surgical tool used directly on the patient during a procedure.
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 (comma separated list FDA assigned to the subject device)
GAM, GAT, GCJ, NAY
Device Description
StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. 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 either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.
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)
A retrospective case review clinical study (n=422) conducted by an academic medical center.
A functional performance test consisting of simulated surgical testing in an animal model was conducted. This included insertion and removal through an 8 mm trocar site in the model to demonstrate that the technique is compatible with the StitchKit device.
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
§ 878.4493 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.
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Image /page/0/Picture/0 description: The image contains 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 14, 2023
Origami Surgical Inc . John Gillespie Management Representative 42 Main St. Madison, New Jersey 07940
Re: K221527
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: Mav 24, 2022 Received: May 26, 2022
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); 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 (OS) 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,
Image /page/1/Picture/5 description: The image shows the name "Deborah A. Fellhauer" in a large, bold font. Below the name, there is a "-S" in a smaller font. The text is black and is set against a white background. The letters "FDA" are faintly visible in the background.
Deborah Fellhauer, RN, BSN Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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| DEPARTMENT OF HEALTH AND HUMAN SERVICES
| Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|---|---|
| Indications for Use | Expiration Date: 06/30/2023 |
| See PRA Statement below. | |
| 510(k) Number ( if known ) | K221527 |
| 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) Summary
| Manufacturer: | K221527
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 |
| Preparation Date: | February 9, 2023 |
| Trade/Device Name: | StitchKit® |
| 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:
- K211792: StitchKit®, product code GAM (Primary), GAT, GCJ and NAY .
Device Description:
StitchKit® is a sterile, single-use plastic canister that is provided pre-loaded with suturing materials with attached needles. The device facilitates endoscopic robotic surgery by introducing multiple strands of suture to the surgical site at one time and allowing for the safe retrieval of the needles. The canister is sized to be passed through a ≥12 mm trocar or passed through an incision sized for an 8 mm trocar under direct endoscopic visualization. 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 either through the ≥ 12 mm trocar or through the 8mm trocar incision in tandem with the 8mm trocar, also under direct endoscopic visualization using the attached retrieval string. It is supplied sterile.
Indication 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.
Comparison to Predicate:
This submission relates to a modification of the instructions for use of an existing device. There is no change to the Intended Use, Indications for Use Statement, nor Technological Characteristics. The proposed change is for modifications to the Instructions for Use for the device, which previously stated that the device may only be inserted or removed via a ≥ 12 mm trocar. The revised instructions add that the device may alternatively be
4
inserted or removed through an existing 8 mm trocar site incision under direct endoscopic visualization by removing the trocar and placing the device through that incision into the surgical field.
This submission was also supported by a retrospective case review clinical study (n=422) conducted by an academic medical center.
Performance Data
A functional performance test consisting of simulated surgical testing in an animal model was conducted. This included insertion and removal through an 8 mm trocar site in the model to demonstrate that the technique is compatible with the StitchKit device.
Conclusion:
Based on the unchanged Indication for Use and Technological Characteristics; functional test data; clinical data; and comparison to the predicate device including risk analysis; we conclude that the proposed StitchKit® device is substantially equivalent to its predicate.