(51 days)
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device is a mechanical knot-tying aid.
No.
The device is described as being used for "approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture," which indicates a surgical tool for binding tissues, not a therapeutic intervention.
No
The device description indicates that the MedicineLodge ZipKnot™ is used for "approximation and/or ligation of soft tissues" using surgical suture, which describes a surgical repair or closure function rather than a diagnostic one.
No
The device description clearly outlines physical components made of PEEK and polypropylene, threaded with suture, and intended for surgical use. It is a physical medical device, not software.
Based on the provided information, the MedicineLodge ZipKnot™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture." This describes a surgical procedure performed directly on a patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical device (button, suture, pod) used for surgical knot tying. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The MedicineLodge ZipKnot™ is clearly a surgical device intended for use during a medical procedure.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NVH
Device Description
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 10-6. The device is biocompatible per ISO-10993 and G95-1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
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)
Not Found
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.
I Feature Drive (#K041216)
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
§ 878.4300 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.
0
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
1
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.
2
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
3
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
4
Image /page/4/Picture/0 description: The image shows the logo for MEDICINELODGE, INC. The logo is two overlapping triangles that form the letter M. Above the logo is the text "JUL 27 2005 K051488".
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™ 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.
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: