(21 days)
[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.
[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.
This device is a tissue marker, not an AI/ML device, so many of the requested elements pertaining to AI/ML device studies (e.g., test set, training set, ground truth experts, MRMC study, standalone performance) are not applicable or detailed in the provided documents. The provided text outlines a 510(k) summary for a medical device called the "[Trade Name] Preloaded Tissue Marker Device" and its associated FDA clearance letter.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Characteristics Equivalence to Predicate Devices | Confirmed equivalent to predicate devices (BiomarC Preloaded Tissue Marker Device K042296 and BiomarC Tissue Marker K063193). |
| Risk Assessment (FMEA) | Performed to assess risks associated with modifications introduced. |
| Biocompatibility | Testing performed and results confirmed substantial equivalence to predicate devices. |
| Sterility | Validation performed and results confirmed substantial equivalence to predicate devices. |
| Distribution Simulation | Testing performed and results confirmed substantial equivalence to predicate devices. |
| Shelf Life | Testing performed and results confirmed substantial equivalence to predicate devices. |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of an AI/ML device. For this physical medical device, specific sample sizes for each type of testing (biocompatibility, sterility, etc.) are not provided in the summary. Data provenance is implied to be from laboratory and engineering testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML device study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as this is not an AI/ML device study.
5. 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:
- No, an MRMC comparative effectiveness study was not done, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, as this is not an AI/ML device. Performance was evaluated for the device itself through various engineering and scientific tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this type of medical device, "ground truth" refers to established scientific and engineering standards and tests. The "ground truth" for the acceptance criteria was based on:
- Predicate Device Equivalence: The performance and characteristics of the already cleared predicate devices.
- Standardized Testing: Biocompatibility standards, sterility validation protocols, distribution simulation standards, and shelf life testing protocols.
- Risk Analysis: Failure Modes and Effects Analysis (FMEA).
8. The sample size for the training set:
- Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable, as this is not an AI/ML device.
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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
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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
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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
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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
§ 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.