(150 days)
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
The Tissue Site Marking System is supplied as a sterile device and is intended for single patient use only. The Tissue Site Marking System is composed of two elements: 1) an implantable device (marker) including a bioabsorable component and a permanent component and 2) a deployment device. The Tissue Site Marking System is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, nuclear, computed tomography, and direct visualization.
The provided text does NOT contain information about acceptance criteria, device performance, or any studies involving AI, human readers, or ground truth establishment.
The document is a 510(k) summary for a "Tissue Site Marking System," which is a medical device for marking sites in soft tissue. It primarily focuses on the regulatory aspects of the device, including:
- Classification Information: Device name, common name, proprietary name, classification, and regulation number.
- Owner/Operator Information: Company details and contact person.
- Device Description: Two components (implantable marker and deployment device) and its intended use with various imaging modalities.
- Indications for Use: Permanent radiographic marking of sites in soft tissue.
- Contraindications: None known.
- FDA Communication: A letter from the FDA confirming substantial equivalence to predicate devices and outlining regulatory responsibilities.
- Indications for Use Form: A standard FDA form reiterating the indications for use.
Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.
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SECTION I - 510(K) Summa FOI Re leasable
JAN 26 2007
Pursuant to § 513(i)(3)(A) of the Food, Drug, and Cosmetic Act, Suros Surgical Systems, Inc. is required to submit with this premarket notification " ... adequate summary of any information respecting safety and effectiveness or state that such information will be made available upon request of any person." Suros Surgical Systems, Inc. chooses to submit a summary of information respecting safety and effectiveness.
| Classification Name: | Marker, Radiographic Implantable | |
|---|---|---|
| Common/Usual Name: | Tissue Site Marking System | |
| Proprietary Name: | None at this time | |
| Device Classification: | Class II | |
| Description | Number | 21 CFR Ref |
| Implantable Clip | NEU | § 878.4300 |
Owner/Operator: Suros Surgical Systems, Inc. - FDA Registration # 3003862400 Northwest Technology Center 6100 Technology Center Drive Indianapolis, IN 46278 317-344-7500
Contact: Heidi Strunk Director, Quality & Regulatory Suros Surgical Systems, Inc. Northwest Technology Center 6100 Technology Center Drive Indianapolis, IN 46278 317-344-7500
DESCRIPTION OF DEVICE
The Tissue Site Marking System is supplied as a sterile device and is intended for single patient use only. The Tissue Site Marking System is composed of two elements:
- an implantable device (marker) including a bioabsorable component and a permanent component and
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SECTION I - 510(K) Summary
- a deployment device.
The Tissue Site Marking System is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, nuclear, computed tomography, and direct visualization.
INDICATIONS FOR USE
The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
CONTRAINDICATIONS
None known
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Image /page/2/Picture/0 description: The image shows a logo for the Ministry of Health & Human Services. The logo is circular and contains the text "MINISTRY OF HEALTH & HUMAN" around the left side of the circle. To the right of the text is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Ms. Heidi H. Strunk Director, Quality and Regulatory Suros Surgical Systems. Inc. 6100 Technology Center Drive INDIANAPOLIS IN 46278
Re: K062528
Trade/Device Name: Tissue Site Marking System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: II Product Code: NEU Dated: December 22, 2006 Received: December 26, 2006
JAN 2 6 7007
Dear Ms. Strunk:
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 indiver 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 Cometic 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. TTo general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulter of de
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular logo with the letters "FDA" in bold, stylized font in the center. Above the letters, the years "1906 - 2006" are printed, indicating a centennial celebration. Below the letters, the word "Centennial" is written in a cursive font, and there are three stars underneath. The logo is surrounded by a dotted circle, and there are small star shapes placed around the perimeter of the circle.
Promoting and Promoting Public Health
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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.
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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours.
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
Device Name: Tissue Site Marking System
Indications for Use: The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.
2528
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ingram
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use:
(Per 21 CFE 801.109)
OR
Over-the Counter Use:
:
(Optional Format 1-2-96)
§ 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.