(30 days)
Not Found
No
The summary describes a physical device (a sleeve) used to facilitate the placement of seeds during brachytherapy. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The device is described as facilitating the introduction of radionuclide seeds and spacers during Brachytherapy procedures, which is a therapeutic medical treatment.
No
This device is a placement sleeve used to introduce radionuclide seeds and spacers during Brachytherapy procedures. Its function is to facilitate the delivery of treatment, not to diagnose a condition or disease.
No
The device description clearly states it is a physical component made of synthetic absorbable polymer or copolymer material, used to facilitate the introduction of seeds and spacers. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a "placement sleeve accessory" used to "facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures." It is used in vivo (within the body) to physically place and orient components.
- Lack of Diagnostic Testing: There is no mention of this device being used to analyze samples or provide diagnostic information based on biological markers. Its function is purely procedural and related to the delivery of therapeutic components.
Therefore, this device falls under the category of a surgical or procedural accessory, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
90 KXK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues or organ tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.5730 Radionuclide brachytherapy source.
(a)
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.(b)
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.
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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.
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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
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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,
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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
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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)
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