CP-SLEEVE

K013975 · Cp Medical · KXK · Feb 22, 2002 · Radiology

Device Facts

• Record ID: K013975
• Device Name: CP-SLEEVE
• Applicant: Cp Medical
• Product Code: KXK · Radiology
• Decision Date: Feb 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component. The CP-Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

Device Story

CP-Sleeve is a synthetic, absorbable braided or non-braided polymer sleeve; functions as an accessory to radionuclide brachytherapy systems. Device holds, orients, and maintains spacing of radioactive seeds and absorbable spacers during implantation into soft or organ tissue. Used by clinicians during brachytherapy procedures to facilitate seed delivery. Device is supplied non-sterile for single use. By maintaining precise seed spacing, the sleeve assists in achieving intended radiation dose distribution within the target tissue.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Comprised of synthetic, absorbable polymer or copolymer material. Braided or non-braided form factor. Designed as a single-use, non-sterile accessory for brachytherapy seed/spacer delivery.

Indications for Use

Indicated for use as an accessory in brachytherapy procedures for soft tissue or organ tissue. Contraindicated for cardiovascular or neurological procedures. Single-use device.

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

• I-125 Rapid Strand accessory Sleeve (K940632 and K010821)
• CP Medical Absorbable Seeding Spacer component (K010621)

Submission Summary (Full Text)

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K013475

and

## Summary of Safety and Effectiveness

In accordance with the Food and Drug Administration Rule to implement provisions of the in dood dails with the t of 1990 and in conformance with 21 CFR 807, this is to serve oale Medical Donseer of Effectiveness for the proposed CP Medical CP-SLEEVE component device.

| Manufacturer: | CP Medical, Inc.<br>2414 NE Pacific Avenue<br>Portland, OR 97232<br>PHONE: [phone]<br>FAX: [phone] |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, Director<br>Regulatory and Quality |
| Device Name: | |
| Trade Name: | Brachytherapy Sleeve Accessory |
| Common Name: | Accessory to seed and spacer components<br>radionuclide brachytherapy Source device |
| Proprietary name: | CP-Sleeve |

System, applicator, radionuclide, Classification: manual & Source, brachytherapy, radionuclide (accessory to)

November 29, 2001 Date Prepared:

Predicate Device: The predicate device to the CP Medical CP-SLEEVE accessory device is the I-125 Rapid Strand 's accessory Sleeve (K940632 and K010821) for the brachytherapy application system and the CP Medical Absorbable Seeding Spacer component (K010621)

Device Description: The CP Medical CP-SLEEVE consists of absorbable polymer or copolymer material, braided and non-braided, which is used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures.

Intended Use: CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component.

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Indications: The CP Medical CP-SLEEVE component device is indicated for use as a accessory in brachytherapy procedures. It is supplied non-sterile as a singleuse device. The CP-Sleeve is indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures.

Comparison of Technological Characteristics: The proposed device, the CP Medical CP-SLEEVE is comprised of an absorbable suture material and is intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. Similarly, the nredicate device is an absorbable suture material intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers.

end

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus consists of a staff with two snakes coiled around it and a pair of wings at the top.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

Ms. Mary Ann Greenawalt Director Regulatory and Quality CP Medical P.O. Box 6724 PORTLAND OR 97208

Re: K013975

Trade/Device Name: CP-Sleeve™ Placement Sleeve for Brachytherapy Procedures Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 29, 2001 Received: December 3, 2001

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. Iisting 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

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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Page 1 of

510(k) Number: K013975

Device Name(s): CP-Sleeve

## Intended Use(s) of the Device:

CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component.

The CP-Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

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necessary

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K013975
510(k) Number

Prescription Use

Or

Over-The-Counter Use

(per 21 CFR 801.109)