(67 days)
Not Found
No
The summary describes a physical brachytherapy seed assembly and its intended use, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is intended to treat localized tumors using brachytherapy, which is a form of radiation therapy, indicating its therapeutic purpose.
No
Explanation: The device description clearly states it is a "brachytherapy seed assembly" intended to "treat localized tumors." It is a therapeutic device that delivers radiation, not a diagnostic device that identifies or characterizes a disease.
No
The device description explicitly states it is an "integral assembly containing radionuclide source seeds, spacers, and markers," which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "brachytherapy seed assembly intended to treat localized tumors". This describes a therapeutic device used for direct treatment within the body.
- Device Description: The description details the physical components of the assembly (radionuclide source seeds, spacers, markers) and its function in delivering radiation for treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
Product codes
KXK
Device Description
The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head, neck, lung, pancreas, breast, uterus, cervix and prostate
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)
Performance testing was conducted on the CuRay Custom Seed Array to demonstrate the integrity, suitability and substantial equivalence of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K043596, K023073, K023179, K030594
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
FEB 2 8 2006
BioLucent. Inc. 510(k) Submission CuRay™ Custom Seed Array
K 053595
4. 510(k) Summary of Safety and Effectiveness
| Device Name: | CuRay™ Custom Seed Array |
|---|---|
| Device Model Number: | CSA-xx |
| Classification Name: | Radionuclide Brachytherapy Source (KXK) |
| 21 CFR, 892.5730 | |
| Device Classification: | Class II |
| Predicate devices: | TheraLoad (K043596) |
| SeedLink (K023073) | |
| Readi-Strand (K023179) | |
| RAPID-Strand (K030594) | |
| Nag Brachyflex Catheters (Cook, Inc.) | |
| Manufacturer: | BioLucent, Inc. |
| 6 Journey, Suite 325 | |
| Aliso Viejo, CA 92656 | |
| Establishment Registration | |
| Number: | 2032338 |
| Official Contact: | Sheryl Higgins |
| BioLucent, Inc. | |
| 6 Journey, Suite 325 | |
| Aliso Viejo, CA 92656 | |
| Phone: (949) 349-1380 (x101) |
Intended Use:
CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
1
Device Description:
The CuRay Custom Seed Array is an integral assembly containing radionuclide source seeds, spacers, and markers which are custom loaded according to a prescribed treatment plan. The CuRay Custom Seed Array is provided sterile and is a single use device.
Technological Characteristics Summary
The CuRay Custom Seed Array is equivalent to the predicate devices, with the same principles of operation and overall technological characteristics.
Performance Data Summary
I erformance testing was conducted on the CuRay Custom Seed Array to demonstrate the integrity, suitability and substantial equivalence of the device.
Conclusion:
Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the CuRay Custom Seed Array is determined to be substantially equivalent to existing legally marketed devices.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2006
Ms. Shervl W. Higgins Director of Engineering BioLucent, Inc. 6 Journey, Suite 325 ALISO VIEJO CA 92656
Re: K053595
Trade/Device Name: CuRay Custom Seed Array Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: December 21, 2005 Received: December 23, 2005
Dear Ms. Higgins:
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.
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) 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 | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 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
4
3. Indications for Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Kr 3 5 5 15
Device Name:
CuRay Custom Seed array
Indications for Use:
CuRay Custom Seed Array is a sterile, custom loaded, brachytherapy seed assembly intended to treat localized tumors such as tumors of the head, neck, lung, pancreas, breast, uterus, cervix and prostate. It can be used either as primary treatment or for residual disease after excision of the primary tumor or for recurring tumors. It may also be used concurrent with or at the completion of other treatment modalities such as external beam radiation therapy or chemotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
(Per 21 CFR 801.109) | OR | Over-The-Counter Use
(Optional Format 1-2-96) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|
| Nancy C Brogdon | |
|---|---|
| (Division Sign-Off) |
Division of Reproductive, Abdominal, and
Radiological Devices
| 510(k) Number | K053595 |
|---|---|
| --------------- | --------- |
Confidential