The MedicineLodge ZipKnot™ consists of a Polyetheretherkeytone (PEEK) button threaded with high strength polyethylene suture Threaders and housed in a polypropylene Threader Pod. The suture is threaded through a series of holes in the ZipKnot™. The holes are designed in such as way as to allow suture to be pulled through the button in one direction but lock the suture if pulled in the opposite direction. Once suture is threaded through the button it can be advanced down the suture arms using the same techniques used in both open and endoscopic surgery when tying sliding surgical knots. Once the ZipKnot™ is in place the excess suture ends are trimmed.

The MedicineLodge ZipKnot™ will be provided sterile for single-use (ASTM 4169), packaged individually in a double tyek pouch. The device will be sterilized by Gamma irradiation (EN 552) or Ethylene Oxide (EN550) including limits for Ethylene Oxide residuals and validated to a sterility assurance level (SAL) of 106. The device is biocompatible per ISO-10993 and G95-1.

AI/ML Overview

This device is a physical medical device (implantable clip/suture fixation device); therefore, the typical acceptance criteria and study designs for artificial intelligence/machine learning (AI/ML) software are not applicable. The provided text outlines the regulatory journey and key characteristics of the MedicineLodge ZipKnot™, focusing on its substantial equivalence to a predicate device rather than performance metrics against a "ground truth" as would be relevant for an AI/ML diagnostic tool.

However, based on the provided text, I can extract information relevant to how its safety and effectiveness were established for regulatory purposes, which can be interpreted in a broader sense as meeting "acceptance criteria":

Acceptance Criteria and Reported Device Performance (as demonstrated for regulatory clearance):

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Justification
Intended Use	Approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.	The MedicineLodge ZipKnot™ is indicated for precisely this use.
Equivalence	Substantially equivalent in intended use, safety, and efficacy to legally marketed predicate devices.	The device was shown to have substantially equivalent performance when compared to the predicate device (Smith & Nephew ULTRABRAID™ / I Feature Drive #K041216).
Biocompatibility	Must be biocompatible.	Biocompatible per ISO-10993 and G95-1.
Sterility	Must be provided sterile for single-use.	Provided sterile for single-use (ASTM 4169), packaged individually in a double tyvek pouch. Sterilized by Gamma irradiation (EN 552) or Ethylene Oxide (EN550) with validated sterility assurance level (SAL) of 10-6 and limits for Ethylene Oxide residuals.
Functionality (Locking Mechanism)	Suture can be pulled through in one direction but locks if pulled in the opposite direction.	"The holes are designed in such as way as to allow suture to be pulled through the button in one direction but lock the suture if pulled in the opposite direction."
Material	Specific materials used for components.	Consists of a Polyetheretherkeytone (PEEK) button, high strength polyethylene suture, and polypropylene Threader Pod.
Manufacturing Standards	Must adhere to Good Manufacturing Practice (GMP).	Subject to GMP requirements (21 CFR Part 820).

Based on the provided text, the following AI/ML-specific questions are not applicable or cannot be answered:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a physical medical device. Testing would involve mechanical, material, and biological evaluations, not a "test set" of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" for this device would be established through bench testing, biocompatibility studies, and comparison to predicate device performance, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable as this is not an AI/ML diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical device like this, "ground truth" would be established through:
- Mechanical Testing: Demonstrating the device's ability to hold suture, withstand forces, and maintain integrity.
- Biocompatibility Testing: According to ISO-10993, to ensure it doesn't cause adverse biological reactions.
- Sterility Validation: Proving the sterilization method achieves the required Sterility Assurance Level (SAL).
- Comparison to Predicate Device: Bench testing and performance data comparing it to the already approved predicate device (Smith & Nephew ULTRABRAID™ / I Feature Drive). The submission states, "The subject device was shown to have substantially equivalent performance when compared to the predicate device."
The sample size for the training set: Not applicable for a physical medical device.
How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) clearance letter for a physical medical device. The "acceptance criteria" revolve around demonstrating substantial equivalence to an existing predicate device through various non-clinical tests (mechanical, sterilization, biocompatibility) rather than through AI/ML performance metrics against a defined dataset and expert "ground truth."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the agency's name, "U.S. Food & Drug Administration," in blue text.

June 23, 2023

Medicinelodge, Inc. M. Mry Sinnott Project Engineer 180 South 600 West Logan, Utah 84321

Re: K051488

Trade/Device Name: Medicinelodge ZipknotTM Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: NVH

Dear M. Mry Sinnott:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 27, 2005. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under 21 CFR 878.4300.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Cynthia Chang, OHT4: Office of Surgical and Infection Control Devices, (301)796-6891, cynthia.chang@fda.hhs.gov.

Sincerely,

Cynthia Chang -S

Cynthia J. Chang, Ph.D. 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

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JUL 27 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

ไ

Ms. M. Mary Sinnott, B.Sc.N. Project Engineer MedicineLodge, Inc. 180 South 600 West Logan, Utah 84321

Re: K051488

Trade/Device Name: MedicineLodge ZipKnot TM Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable polyethylene terephthalate surgical suture Regulatory Class: II Product Code: NVH Dated: June 3, 2005 Received: June 13, 2005

Dear Ms. Sinnott:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. M. Mary Sinnott, B.Sc.N.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Miller

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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51488

Revised

INDICATIONS FOR USE
510(k) Number (if known):	K051488
Device Name:	MedicineLodge ZipKnot TM

Indications for Use:

The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

Mark H. Milburn

(Division Sign-Off) Division of General. Restorative and Neurological Devices

510(k) Number_

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

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SUMMARY OF SAFETY AND EFFECTIVENESS

Device Name

Classification Name: Classification: Common and Usual Name: Proprietary Name:

Implantable Clip 21 CFR §878.4300, Class II Suture Fixation Device MedicineLodge ZipKnot™

Predicate Device

I Feature Drive (#K041216) currently marketed by Smith & Nephew (Andover, MA).

Summary

This summary of 510(k) safety and effectiveness is being submitted in accordance with requirements of SMDA 1990.

The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

The MedicineLodge ZipKnof™ consists of a Polyetheretherkeytone (PEEK) button threaded with high strength polyethylene suture Threaders and housed in a polypropylene Threader Pod. The suture Situngal portytene sattre through a series of holes in the ZipKnot™. The holes are designed in such as way as to allow suture to be pulled through the button in one direction but lock the suture if pulled in the opposite direction. Once suture is threaded through the button it can be advanced down the suture arms using the same techniques used in both open and endoscopic surgery when tying sliding surgical knots. Once the ZipKnot™ is in place the excess suture ends are trimmed.

The MedicineLodge ZipKnot™ is equivalent in intended use, safety, and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device.

The MedicineLodge ZipKnot™ is considered substantially equivalent to Smith & Nephew ULTRABRAID™.

Contact: M. Mary Sinnott, B.Sc.N, M.S. Project Engineer MedicineLodge, Inc. 180 South 600 West Logan, UT 84321 (435) 753-7675 ext. 15

Date:

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.