PRELOADED TISSUE MARKER DEVICE

K100994 · Carbon Medical Technologies, Inc. · NEU · Apr 30, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100994
• Device Name: PRELOADED TISSUE MARKER DEVICE
• Applicant: Carbon Medical Technologies, Inc.
• Product Code: NEU · General, Plastic Surgery
• Decision Date: Apr 30, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4300
• Device Class: Class 2

Intended 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 Story

Sterile, single-use tissue marker; consists of pyrolytic carbon-coated zirconium oxide marker incorporated into lyophilized BiomarC delivery gel. Placed into soft tissue during open, percutaneous, or endoscopic procedures. Visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, CT), ultrasound, and MRI. Used by clinicians to mark surgical locations for future identification.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing, sterility validation, distribution simulation, and shelf-life testing.

Technological Characteristics

Pyrolytic carbon-coated zirconium oxide marker; lyophilized BiomarC delivery gel. Sterile, nonpyrogenic, single-use. Radiopaque on x-ray, mammography, fluoroscopy, kV, CT, ultrasound, and MRI.

Indications for Use

Indicated for radiographic marking of soft tissue at surgical sites during or for future surgical procedures.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• BiomarC Preloaded Tissue Marker Device (K042296)
• BiomarC Tissue Marker (K063193)

Submission Summary (Full Text)

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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: [phone] 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 [phone] or [phone] 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