N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000

K973037 · Avid N.I.T., Inc. · IWJ · Jan 27, 1998 · Radiology

Device Facts

• Record ID: K973037
• Device Name: N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000
• Applicant: Avid N.I.T., Inc.
• Product Code: IWJ · Radiology
• Decision Date: Jan 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5650
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a racionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

Device Story

Manually operated applicator for delivery of radionuclide seeds into body tissue; used for radiation therapy, specifically transperineal prostate seed implantation. Device facilitates precise placement of radioactive sources; operated by physicians in clinical/surgical settings. Output is the physical delivery of the seed to the target site; assists in localized cancer treatment. Benefits include targeted radiation delivery to prostate tissue while minimizing exposure to surrounding structures.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Manually operated mechanical applicator for radionuclide seeds. No electronic components, software, or energy sources. Materials and sterilization methods not specified in document.

Indications for Use

Indicated for use in patients requiring radiation therapy via radionuclide seed implantation, specifically for transperineal prostate seed application.

Regulatory Classification

Identification

A manual radionuclide applicator system is a manually operated device intended to apply a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 27 1998

Joseph Harms President Needle & Infusion Technologies, Inc. 917 Klosterman Rd. Tarpon Springs, FL 34689

Re:

K973037 NIT Radionuclide Seed Applicator Dated: January 15, 1997 Received: January 16, 1997 Regulatory class: I 21 CFR 892.5650/Procode: 90 IWJ

Dear Mr. Harms:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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.

If your device is classified (see above) into either 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

This ietter will allow you to begin marketing your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html" ........

Sincerely yours,

W. Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(kg) Number (1f known): 10 30 SCS 7

N.L.T-+-Inc-Radionuclide Seed Applicator Device Name:

## Indications For Use:

The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a racionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use***_***_

(Optional Format 1-2-98)

Shroid C. Bezborn

(Division Sign-Off) minal, ENT, Division of Reproductive, Abd and Radiological Devices 510(k) Number _

TOTAL P.06