(42 days)
The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.
The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.
The provided document K071550 describes the CP Medical Pre-waxed Needles with Gold Fiduciary Markers. This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive standalone performance evaluation.
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert contributions, adjudication methods, and MRMC studies, which are typical for AI/CAD device submissions, is not applicable or available in this document. The submission relies on design verification and a comparison of materials and packaging to a predicate device.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly defined in terms of specific performance metrics with acceptance criteria. The submission focuses on substantial equivalence to the predicate device (Best Radiopaque Marker, K043117) rather than setting and meeting de novo performance targets. The "acceptance criteria" here implicitly relate to demonstrating equivalent materials, packaging, and the intended function through design verification.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Material Equivalence to Predicate Device | The CP Medical Pre-waxed Needles with Gold Fiduciary Markers use equivalent materials to the Best Radiopaque Marker (K043117). (No specific material specifications or performance metrics provided.) |
| Packaging Equivalence to Predicate Device | The CP Medical Pre-waxed Needles with Gold Fiduciary Markers use equivalent packaging to the Best Radiopaque Marker (K043117). (No specific packaging validation results provided, only statement of equivalence.) |
| Sterilization Validation | Sterilization validation activities were performed. (Specific validation results or acceptance criteria for sterilization are not detailed beyond the statement of completion.) |
| Package Validation | Package validation activities were performed. (Specific validation results or acceptance criteria for package integrity are not detailed beyond the statement of completion.) |
| Product Integrity (Needles) | Product integrity for the pre-waxed needles component was "previously performed." (References K024372 and states no new testing required for this component.) Specifics of this prior testing or its acceptance criteria are not provided in this document. |
| Intended Use Fulfillment (Localization for Radiation Therapy) | The device is designed for interstitial placement of gold seed markers, which serve as localization devices for radiation therapy, functionally equivalent to the predicate device. (No specific clinical performance metrics provided.) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a typical AI/CAD performance study. The submission for this type of device (implantable marker/needle) focuses on engineering design verification rather than clinical test set performance. No "test set" of patient data (images, pathology, etc.) was used for evaluating algorithm performance. The "testing and verification activities" refer to engineering and manufacturing tests (sterilization, packaging, product integrity).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. There was no test set requiring expert ground truth establishment for this device submission.
4. Adjudication Method for the Test Set
Not applicable. There was no test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is not relevant for an implantable radiographic marker and needle device, which does not involve human readers interpreting imaging with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This device is a physical medical instrument, not an algorithm, so standalone performance in the context of AI is not applicable.
7. The Type of Ground Truth Used
Not applicable in the context of AI/CAD ground truth. The "ground truth" for this submission is whether the physical device meets engineering specifications and is equivalent to the predicate device in materials, packaging, and intended use. This is established through design verification rather than expert consensus on clinical data or pathology reports.
8. The Sample Size for the Training Set
Not applicable. This device submission does not involve a "training set" as it's not an AI/CAD system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There was no training set for this device.
Summary of Approach:
The K071550 submission for the CP Medical Pre-waxed Needles with Gold Fiduciary Markers followed a substantial equivalence pathway to a legally marketed predicate device (Best Radiopaque Marker, K043117). The primary evidence presented involved:
- Comparison of materials and packaging: Stating that they are equivalent to the predicate device.
- Design Verification: Confirming that engineering design inputs were achieved through activities like sterilization validation and package validation. Product integrity for the needle component was referenced as previously performed (K024372).
This type of submission does not involve the detailed performance studies or data sets typically associated with AI/CAD devices, as the product is a conventional medical instrument.
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Image /page/0/Picture/0 description: The image shows the logo for CP Medical. The words "CP Medical" are in a sans-serif font, with the letters "CP" in a shaded box. Below the logo, the words "Portland, OR USA" are written in a smaller font.
JUL ] 8 2007
510(k) SUMMARY OF SAFETY & EFFECTIVENESS
| Device Name: | Pre-Waxed Needles with Gold Fiduciary Markers |
|---|---|
| Device Model Number: | FN17-xx, FN18-xx |
| Classification Name: | Implantable Radiographic Marker (NEU) |
| Device Classification: | Class II, 21 CFR 878.4300 |
| Predicate Devices: | Best Radiopaque Marker, K043117 |
CP Medical 803 NE 25th Ave. Portland, OR 97232 USA
3032563
Manufacturer:
Establishment Registration Number:
Official Contact:
Betsy Cortelloni Regulatory Affairs Manager Theragenics Corporation® 5203 Bristol Industrial Way Buford, GA 30518 Phone: 770-271-0233 Fax: 770-831-4369
Intended Use: The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.
Device Description: The CP Medical Pre-waxed Needles with Gold Fiduciary Markers are designed for use in conjunction with conventional radiation therapy methods. The product consists of one (1) solid gold seed marker, loaded into a standard 17 or 18 gauge brachytherapy needle that has been preplugged with bone wax (CP Medical, K024372). The loaded needles are packaged individually or in groups of three. The packaged needles are sterilized via ethylene oxide.
Substantial Equivalence Comparison: The CP markers are compared to the gold "Radiopaque Marker" offered by Best Medical International, Inc. The two devices use equivalent materials and packaging.
Design Verification: The testing and verification activities performed for this product include sterilization validation and package validation. Product integrity was previously performed on the pre-waxed needles.
Conclusion: The results of verification testing confirmed that design inputs were achieved and that the CP Markers are substantial equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL 1 8 2007
CP Medical, Inc. c/o Ms. Betsy Cortelloni RA/OA Manager Theragenics Corporation 5203 Bristol Industrial Way BUFORD GA 30518
Re: K071550
Trade/Device Name: Pre-waxed Needles with Gold Fiduciary Markers Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: June 4, 2007 Received: June 6, 2007
Dear Ms. Cortelloni:
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 (Premarket Approval), 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.
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Protecting and Promoting Public Health
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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.
This letter will allow you to begin marketing your device as described in your Section 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:
21 CFR 876 xxxx 21 CFR 884.xxxx 21 CFR 892.xxxxx Other
(Gastroenterology/Renal/Urology) 240-276-0115 (Obstetrics/Gynecology) 240-276-0115 (Radiology); 240-276-0120 240-276-0100
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.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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INDICATIONS FOR USE FORM
Page 1 of _ 1 .
510(K) number (if known): K071550
Device Name: Pre-waxed Needles with Gold Fiduciary Markers
Indications for Use:
The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ X (Per 21 CFRR 801.109)
OR
Over-The-Counter Use_
Helin Lewer
(Division Sign-Off Division of Reproductive, Abdominal and Radiological Devices 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.