(238 days)
Not Found
No
The summary describes a physical tissue marker and its visibility across imaging modalities, with no mention of software, algorithms, or AI/ML capabilities.
No
The device is used to mark soft tissue for radiographic visualization, not to treat a disease or condition.
No
The device is a tissue marker used to radiographically mark soft tissue for future surgical procedures or during a surgical procedure, not to diagnose a condition.
No
The device description clearly states it is a "polymeric discrete marker" which is a physical object, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes. This testing is performed outside of the living body (in vitro).
- KMD-Mark I Tissue Marker Function: The KMD-Mark I Tissue Marker is a physical marker placed inside the body (in vivo) during a surgical procedure. Its purpose is to provide a visible reference point on imaging modalities for future procedures or follow-up. It does not analyze or test a specimen taken from the body.
The device description and intended use clearly indicate its function is to mark tissue within the body for imaging purposes, not to perform diagnostic testing on a sample.
N/A
Intended Use / Indications for Use
The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
KMD-Markl Tissue Marker is a sterile, single patient use, polymeric discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). KMD-Mark1 Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI)
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)
In Vitro and In vivo preclinical testing were performed to verify and validate the safety and effectiveness of the product. These tests included sterilization validation to ISO 11135; biocompatibility testing per ISO 10993-1; MRI safety testing per F119, F2182, and F2034; and radiographic visualization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Kent Medical Devices, Inc.
Confidential
K 093473
1 of 2
510(k) Summary
| Date Submitted: | November 5, 2009
JUL - 2 2010 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Kent Medical Devices, Inc.
4169 Reservoir Boulevard
Minneapolis, MN 55421 |
| Device Trade Name: | KMD-Mark1 Tissue Marker |
| Contact: | Mr. Justin Eggleton
Director, Spine Regulatory Affairs
Musculoskeletal Clinical Regulatory Advisers, LLC
1331 H Street NW, 12th Floor
Washington, DC 20005
Phone: (202) 552-5800
Fax: (202) 552-5798 |
| Classification: | 21 CFR §878.4300 |
| Class: | II |
| Product Code: | NEU |
Indications For Use:
The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Device Description:
KMD-Markl Tissue Marker is a sterile, single patient use, polymeric discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI). KMD-Mark1 Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Predicate Device(s) Reference:
The KMD-Markl Tissue Marker was shown to be substantially equivalent to the following previously cleared devices and has the same indications for use, design, and function:
K072219 Cytophil Tissue Marker
K070436 BiomarC Tissue Marker
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Confidential
U093473
2 of 2
Performance Standards:
In Vitro and In vivo preclinical testing were performed to verify and validate the safety and effectiveness of the product. These tests included sterilization validation to ISO 11135; biocompatibility testing per ISO 10993-1; MRI safety testing per F119, F2182, and F2034; and radiographic visualization.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL - 2 2010
Kent Medical Devices, Inc. % Musculoskeletal Clinical Regulatory Advisers, LLC Mr. Justin Eggleton Director, Spine Regulatory Affairs 1331 H. Street Northwest, 12th Floor Washington, District of Columbia 20005
Re: K093473
Trade/Device Name: KMD-Mark1 Tissue Marker Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: July 1, 2010 Received: July 2, 2010
Dear Mr. Eggleton:
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. 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
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Page 2 - Mr. Justin Eggleton
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21.CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please . go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Wilkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and · Radiological Health
Enclosure
4
Indications for Use 4.
510(k) Number (if known): K093473
Device Name: KMD-Mark1 Tissue Marker
The KMD-Mark I Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.
Prescription Use (Part 29 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (29 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)
Daniel Krone for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093473