SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL

K021311 · Cp Medical · KXK · Jul 13, 2002 · Radiology

Device Facts

• Record ID: K021311
• Device Name: SYNTHETIC ABSORBABLE SEEDING SPACERS MADE OF POLYDIOXANONE MATERIAL
• Applicant: Cp Medical
• Product Code: KXK · Radiology
• Decision Date: Jul 13, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers are single-use, absorbable seeds comprised of spacer material used to provide a predetermined space between radionuclide seeds for brachytherapy procedures.

Device Story

Device consists of small cylindrical spacers made of absorbable polydioxanone material. Used during brachytherapy procedures to maintain predetermined spacing between implanted radionuclide seeds. Device is single-use and implanted into soft or organ tissue by a physician. Spacers provide physical separation of radioactive sources to ensure desired radiation dose distribution. Material is absorbable, eliminating need for removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Material: Polydioxanone (synthetic absorbable). Form factor: Small cylindrical spacer. Principle: Mechanical spacing of radionuclide seeds. Sterilization: Not specified.

Indications for Use

Indicated for use in brachytherapy, soft tissue, or organ tissue. Contraindicated for use during cardiovascular or neurological procedures.

Regulatory Classification

Identification

A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.

Special Controls

*Classification.* Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• CP Medical absorbable seeding spacers (K010621)
• CP Medical absorbable seeding spacers (K013964)

Submission Summary (Full Text)

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## JUL 1 3 2002

# Summar

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807, this is to serve as a Summary of Safety and Effectiveness for the proposed CP Medical Monofilament spacer product: :

#### Manufacturer:

CP Medical. Inc. 2414 NE Pacific Avenue Portland, OR 97232 PHONE: [phone] FAX: [phone]

Contact Person: Mary Ann Greenawalt, Director Requlatory and Quality or Sue Ridge, Regulatory Associate

#### Device Name:

| Trade Name: | Polydioxanone Synthetic Absorbable Seeding Spacers |
|-------------------|-----------------------------------------------------------------------------------------------------|
| Common Name: | Accessory to applicator and accessory<br>to radionuclide brachytherapy Source |
| Proprietary name: | Polydioxanone Synthetic Absorbable Seeding Spacers |
| Classification: | System, applicator, radionuclide,<br>manual & Source, brachytherapy.<br>radionuclide (accessory to) |

Date Prepared. April 17, 2002

Predicate Device: The predicate device to the CP Medical Polydioxanone Synthelic Absorbable Seeding Spacers is the CP Medical device, absorbable seeding spacers [K010621 and K013964].

Device Description: The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacer consists of absorbable spacer material, which is cut into a small cylindrical seed spacer utilized to provide space between the radionuclide seeds as they are implanted into the body.

Intended Use: The CP Medical Polydioxanone Synthetic Absorbable Seeding Spacers are single-use, absorbable seeds comprised of spacer material used to provide a predetermined space between radionuclide seeds for brachytherapy procedures.

Indications: CP Medical's synthetic absorbable seeding spacers, made of polydioxanone material, are indicated for use in brachytherapy, soft tissue, or organ tissue but should not be used during cardiovascular or neurological procedures.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUL 1 3 2002

Ms. Mary Ann Greenawalt Director. Regulatory and Quality CP Medical, Inc. 836 NE 24th Avenue PORTLAND OR 97232

Re: K021311

Trade/Device Name: Synthetic Absorbable Seeding Spacers made of Polydioxanone Material Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: April 17, 2002 Received: April 25, 2002

Dear Ms. Greenawalt:

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.

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); 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.

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This letter will allow you to begin marketing your device as described in 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html.

Sincerely yours,

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: Koz1311

Device Name(s): Synthetic absorbable seeding spacer made of polydioxanone material

### Indications for Use(s) of the Device:

CP Medical's synthetic absorbable seeding spacers made of polydioxanone material are indicated for use in brachytherapy, soft tissues, or organ tissue but should not be used during cardiovascular or neurological procedures.

Please do not write below this line - continue on another page if necessary

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(per 21 CFR 801.109)

or

Over-The-Counter Use

(Division Sign-Off)

Division of Reproductive, and Radiological Device 5 1 O(k) Number