(52 days)
CP Medical's absorbable seeding spacers are intended to be used to maintain a predetermined space between radionuclide seeds for the introduction of the seeds into the body during brachytherapy procedures. Seeding spacers are indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.
The CP Medical Accu-Space and BioSpacer consists of absorbable spacer material and is a small cvlindrical component device utilized to provide space between the radionuclide seeds as they are implanted into the body.
This document (K013964) is a 510(k) premarket notification for an absorbable seeding spacer product. It's a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device, not a study proving device performance against acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not present in this type of document.
The document primarily focuses on:
- Manufacturer and Device Information: Name, contact, device name (Absorbable Seeding Spacers), classification, and date.
- Predicate Device: K010621 (Accu-Space absorbable seeding spacers).
- Device Description: Small cylindrical absorbable component used to maintain space between radionuclide seeds during brachytherapy.
- Indications for Use: To maintain predetermined space between radionuclide seeds for introduction into the body during brachytherapy procedures in soft or organ tissue, but not in cardiovascular or neurological procedures.
- FDA Determination: A letter from the FDA stating that the device is substantially equivalent to legally marketed predicate devices and can be marketed.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria and study details based on the provided text. This 510(k) submission does not contain the information typically found in a clinical study report that would address those points.
{0}------------------------------------------------
Summary
KO13964
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 CP Medical absorbable seeding spacer product.
| Manufacturer: | CP Medical, Inc.2414 NE Pacific AvenuePortland, OR 97232PHONE: (503) 232-1555FAX: (503) 230-9993 |
|---|---|
| Contact Person: | Mary Ann Greenawalt, DirectorRegulatory and Quality |
| Device Name: | |
| Trade Name: | Absorbable Seeding Spacers |
| Common Name: | Accessory to applicator and accessoryto radionuclide brachytherapy Source |
| Proprietary name: | Accu-Space™ or BioSpacer™Absorbable Seeding Spacers |
| Classification: | System, applicator, radionuclide,manual & Source, brachytherapy,radionuclide (accessory to) |
| Date Prepared: | December 26, 2001 |
Predicate Device: The predicate device to the CP Medical BioSpacer or Accu-Space seeding spacer is the Accu-Space absorbable seeding spacers, K010621.
Device Description: The CP Medical Accu-Space and BioSpacer consists of absorbable spacer material and is a small cvlindrical component device utilized to provide space between the radionuclide seeds as they are implanted into the body.
Indications for Use: The absorbable seeding spacers are intended tob e used to maintain a predetermined space between radionuclide seeds for the introduction of seeds into the body during brachytherapy procedures. Seeding spacers are indicated for use in soft tissue or organ tissue but should not be used during cardiovascular or neurological procedures. end
{1}------------------------------------------------
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2002
Ms. Mary Ann Greenawalt Director, Regulatory and Quality CP Medical P.O. Box 6724 PORTLAND OR 97208
Re: K013964
Trade/Device Name: Absorbable Seeding Spacers Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 26, 2001 Received: December 28, 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, 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.
{2}------------------------------------------------
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
{3}------------------------------------------------
Page 1 of 1
013964 510(k) Number (if known):
Absorbable Seeding Spacers Device Name:
Indications for Use:
CP Medical's absorbable seeding spacers are intended to be used to maintain a predetermined space between radionuclide seeds for the introduction of the seeds into the body during brachytherapy procedures. Seeding spacers are 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)
Prescription Use_
or
Over the Counter Use _________________________________________________________________________________________________________________________________________________________
(per 21 CFR 801.109)
Nancy C. Broadion
(Division Sign-Off) (0
Division of Reproductive, Abdominal,
and Radiological Devices K013964
510(k) Number
§ 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.