(81 days)
Not Found
No
The summary describes a physical accessory for brachytherapy procedures made of absorbable polymer. There is no mention of software, algorithms, or any computational processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No
The device is an accessory used to facilitate the introduction of radionuclide seeds and spacers for Brachytherapy procedures; it does not directly treat a condition.
No
The device is described as an accessory for introducing radionuclide seeds during brachytherapy procedures, focusing on physical placement and spacing rather than identifying or analyzing a medical condition.
No
The device description explicitly states it is made of "absorbable polymer or copolymer material, braided and non-braided," indicating it is a physical, material-based 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 medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The description clearly states that this device is a "placement sleeve accessory" used during Brachytherapy procedures to facilitate the introduction of radionuclide seeds and spacers into the body. It is used to orient, hold, carry, and maintain spacing of these components within the body.
- No Specimen Examination: There is no mention of this device being used to examine any specimens derived from the human body. Its function is purely mechanical and procedural, aiding in the delivery of therapeutic materials.
Therefore, the intended use and function of this device fall outside the scope of an In Vitro Diagnostic.
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 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.
Product codes
90 KXK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
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.
2414 NE Pacific Avenue
Portland, OR 97232
PHONE: (503) 232-1555
FAX: (503) 230-9993 |
|-------------------|------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Mary Ann Greenawalt, Director
Regulatory and Quality |
| Device Name: | |
| Trade Name: | Brachytherapy Sleeve Accessory |
| Common Name: | Accessory to seed and spacer components
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.
1
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
2
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.
3
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 | (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 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 (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
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.
Please do not write below this line - continue on another page if
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)