(21 days)
No
The device description and intended use focus on a physical tissue marker and delivery gel, with no mention of software, algorithms, or data processing that would indicate AI/ML. The performance studies described are related to physical properties and equivalence, not algorithmic performance.
No.
The device's stated indication is to "radiographically mark soft tissue at the surgical site," which is a diagnostic aid, not a therapeutic intervention.
No
The device is described as a "Preloaded Tissue Marker" used to "radiographically mark soft tissue at the surgical site" for future procedures. Its purpose is to physically mark a location, not to diagnose a condition or disease.
No
The device description clearly states it is a physical tissue marker consisting of a zirconium oxide marker and delivery gel, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures." This is a direct intervention on the patient's body for marking purposes, not for analyzing a sample taken from the body to diagnose a condition.
- Device Description: The device is a physical marker placed into soft tissue. It is not designed to analyze biological samples like blood, urine, or tissue biopsies.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for marking a location within the body for imaging purposes.
N/A
Intended Use / Indications for Use
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Product codes
NEU
Device Description
[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded 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, fluoroscopy, kV, and CT) 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)
A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. Biocompatibility testing, sterility validation, distribution simulation and shelf life testing results confirmed that the modified device, [Trade Name] Preloaded Tissue Marker Device, was substantially equivalent to the predicate devices.
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
ATTACHMENT 4
510(K) SUMMARY
Submitter's Name, Address and Date of Submission
Tina M. Wittchow Vice President, Professional & Technical Services Carbon Medical Technologies, Inc. 1290 Hammond Road Saint Paul, MN 55110
651-653-8512 Phone: 651-407-1975 Fax:
Submitted: April 8, 2010
Device Name
| Trade Name: | [Trade Name] Preloaded Tissue Marker Device |
|---|---|
| Classification Name: | Implantable Clip, 21 CFR 878.4300 |
| Common/Usual Name: | Tissue Marker |
Predicate Device
BiomarC Preloaded Tissue Marker Device (K042296) BiomarC Tissue Marker (K063193)
Indication for Use
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Device Description
[Trade Name] Preloaded Tissue Marker Device is a sterile, nonpyrogenic, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. The [Trade Name] Preloaded Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.
Technological Characteristics and Performance
The technological characteristics are equivalent to the predicate devices. A Failure Modes and Effects Analysis (FMEA) was performed in order to assess the risks associated with the modifications introduced. Biocompatibility testing, sterility validation, distribution simulation and shelf life testing results confirmed that the modified device, [Trade Name] Preloaded Tissue Marker Device, was substantially equivalent to the predicate devices.
APR. 30 2010
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Carbon Medical Technologies, Inc. % Ms. Tina M. Wittchow VP, Professional & Technical Services 1290 Hammond Road St. Paul, Minnesota 55110
APR 3 0 2010
Re: K100994
Trade/Device Name: Preloaded Tissue Marker Device Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: April 8, 2010 Received: April 9, 2010
Dear Ms. Wittchow:
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 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
2
Page 2 - Ms. Tina M. Wittchow
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.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known): K 100994
Device Name: [Trade Name] Preloaded Tissue Marker Device
Indications for Use:
[Trade Name] Preloaded Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Keane for MXM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K100994