(28 days)
Not Found
Not Found
No
The summary provides no information suggesting the use of AI or ML. The device description and performance study sections are empty, and there are no mentions of AI, DNN, or ML.
No
The device is used for approximation and ligation of soft tissues, which describes a surgical function rather than a therapeutic one (i.e., treating a disease or disorder).
No
The device is described as being for "approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture," which indicates a surgical function (e.g., closing wounds, tying off vessels), not a diagnostic one.
No
The intended use describes a device for approximating and ligating soft tissues using surgical suture, which strongly implies a physical, hardware-based device for manipulating suture. There is no mention of software as the primary or sole component.
Based on the provided information, the MedicineLodge ZipKnot™ is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture." This describes a surgical device used in vivo (within the body) for physical manipulation of tissues.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Detecting diseases or conditions
- Using reagents or assays
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The MedicineLodge ZipKnot™'s function is purely mechanical and surgical.
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
FZP
Device Description
Not Found
Mentions image processing
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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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MEDICINELODGE, Inc. % Ms. M. Mary Sinnot Principal Engineer 180 South 600 W. Logan, UT 84321
OCT - 5 2007
Re: K072525
Trade/Device Name: MedicineLodge ZipKnot™ Suture Fixation Device Regulation Number: 21 CFR 878.4300 Regulation Name: Inplantable clip Regulatory Class: II Product Code: FZP Dated: August 31, 2007 Received: September 7, 2007
Dear Ms. M. Mary Sinnot:
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.
1
Page 2 - Ms. M. Mary Sinnot
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 (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
DSP Dit
2010/5/07
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and
Radiological Health
Enclosure
2
072525
Indications For Use Statement
:
510(k) Number (if known):
Device Name:
MedicineLodge ZipKnot™ Suture Fixation Device
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.
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number L072515
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Part 21 CFR 801 Subpart D)
5
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)