← Product Code [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK) · K034062 # CP SLEEVE AND RIVER SLEEVE (K034062) _Cp Medical · KXK · Jan 30, 2004 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K034062 ## Device Facts - **Applicant:** Cp Medical - **Product Code:** [KXK](/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK.md) - **Decision Date:** Jan 30, 2004 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.5730 - **Device Class:** Class 2 - **Review Panel:** Radiology - **Attributes:** Therapeutic ## Indications for 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 Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures. ## Device Story Carrier Sleeve is a synthetic absorbable polymer/copolymer accessory (braided or non-braided) for brachytherapy. Used by clinicians to orient, hold, carry, and maintain spacing of radionuclide seeds and absorbable spacers during implantation into soft or organ tissue. Facilitates introduction of radioactive components into the body. Single-use device; supplied sterile or non-sterile. ## Clinical Evidence Bench testing only. ## Technological Characteristics Synthetic absorbable polymer or copolymer material; braided or non-braided form factor; single-use; non-sterile or sterile. Functions as a mechanical carrier/spacer for brachytherapy seeds. ## Regulatory 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 Placement Sleeve for Brachytherapy Procedures ([K013975](/device/K013975.md)) - RIVER Medical Absorbable Seeding PDO Spacer component ([K021311](/device/K021311.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ KO34062 ## JAN 2 0 2004 ## Summary of Safety and Effectiveness 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 CP-SLEEVE component device, Special 510(k). | Manufacturer: | CP Medical, Inc.
2414 NE Pacific Avenue
Portland, OR 97232
PHONE: (503) 232-1555
FAX: (503) 230-9993 | |-------------------|------------------------------------------------------------------------------------------------------------------| | Contact Person: | Mary Ann Greenawalt, VP
Legal & Regulatory Affairs | | Device Name: | | | Trade Name: | Brachytherapy Sleeve Accessory | | Common Name: | Accessory to seed and spacer components and
radionuclide brachytherapy Source device | | Proprietary name: | Carrier Sleeve | | Classification: | System, applicator, radionuclide,
manual & Source, brachytherapy,
radionuclide (accessory to) | Date Prepared: December 15, 2003 Predicate Device: The predicate device to the CP Medical CARRIER SLEEVE accessory device is the CP Medical, K013975, Placement Sleeve for Brachytherapy Procedures and the RIVER Medical Absorbable Seeding PDO Spacer component (K021311) Device Description: The CP Medical CARRIER SLEEVE consists of synthetic 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. -0- {1}------------------------------------------------ Indications: The CP Medical CARRIER SLEEVE component device is indicated for use as a accessory in brachytherapy procedures. It is supplied non-sterile or sterile as a single-use 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 CARRIER SLEEVE is comprised of a synthetic absorbable material and is intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. Similarly, the predicate devices are composed of synthetic absorbable material intended to facilitate the loading, delivery and implantation of radioactive seeds and spacers. end {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 3 0 2004 Ms. Mary Ann Greenawalt VP Legal & Regulatory Affairs CP Medical, Inc. RIVER Medical (O/O # 9052608) 836 NE 24th Avenue PORTLAND OR 97208 Re: K034062 Trade/Device Name: Carrier-Sleeve Synthetic Absorbable Braided and Non-Braided Placement Sleeve Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 30, 2003 Received: January 5, 2004 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 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. 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, {3}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will and in you've one finding of substantial equivalence of your device to a legally marketed predicated 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 It you dostro positiv at one of the following numbers, based on the regulation number at the top of the letter: | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other of Ostapharket notification" (21CFR Part 807.97) you may obtain. 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 (800) 638-2041 or (301) 443-6597 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 {4}------------------------------------------------ Page _ 1 of__1 ___ 510(k) Number: K034062 Device Name(s): Carrier-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 Carrier Sleeve is indicated for use in 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 ecessary Concurrence of CDRH, Office of Device Evaluation (ODE) Daniel Le. Segerman (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K034062 510(k) Number Prescription Use Over-The-Counter Use (per 21 CFR 801.109) ਾ -3- --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K034062](https://fda.innolitics.com/submissions/RA/subpart-f%E2%80%94therapeutic-devices/KXK/K034062) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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