(42 days)
Not Found
No
The summary describes a physical medical device (brachytherapy source) and its intended use, manufacturing process, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is 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, specifically for permanent interstitial implantation of selected localized tumors.
No
The device is described as a source of nuclear radiation for therapy, indicated for permanent interstitial implantation of localized tumors. It is a treatment device, not one used for diagnosis.
No
The device description clearly states it consists of physical components like absorbable seeding spacers, radionuclide brachytherapy sources, a sleeve, and prostate seeding needles. It is also sterilized and shipped as a physical product.
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.
- RAPID Strand™ Rx Function: The description clearly states that RAPID Strand™ Rx is a device intended to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy. It is a therapeutic device, not a diagnostic one. It delivers radiation to treat tumors, it does not analyze samples from the body to diagnose or monitor a condition.
Therefore, RAPID Strand™ Rx falls under the category of a therapeutic medical device, specifically a brachytherapy source, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and 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.
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ Rx may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Product codes
90-KXK, KXK
Device Description
RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
body surface or into a body cavity or tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical specialist's prescription
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
Non-clinical test data that includes design validation, process validation, bench test results and sterilization validation have been provided in the Section-H. Based on the results, one can conclude that changes made to the design and manufacturing processes do not raise any question about the safety and efficacy of the subject device for its intended use.
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.
0
NOV 3 0 2006
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The following 510(k) Summary of Safety and Effectiveness is prepared and provided in accordance with the requirements of 21 CFR 807.92 as amended under the Safe Medical Devices Act of 1990 (SMDA).
Submitter's Information
| Submitter Name: | Subhash Patel, RAC
Consultant |
|-------------------------------------------|----------------------------------------------------------------|
| Sponsor Name:
Address: | Oncura Inc.
401 Plymouth Road
Plymouth Meeting, PA 19462 |
| Contact Name:
Phone Number:
E-mail: | Subhash Patel, RAC
(732) 821-7021
spatelraqpro@yahoo.com |
Summary Prepared Date:
Subject Device Information
| Trade Name: | RAPID Strand™ Rx |
|---|---|
| Common Name: | Radionuclide Brachytherapy Source |
| Class: | II |
| Classification: | 21 CFR 892.5730 |
| Product Code: | 90-KXK |
Predicate Devices
Legally marketed device to which equivalence is claimed.
October 5, 2006
| Trade Name: | RAPID Strand™ |
|---|---|
| Model: | 7000 |
| Common Name: | Radionuclide Brachytherapy Source |
| Class: | II |
| Classification: | 21 CFR 892.5730 |
| Product Code: | 90-KXK |
| Cleared in 510(k): | K030594 and K940632 |
| Owner/Holder: | Medi-Physics, Inc., Arlington Heights, IL |
1
Description of Device
RAPID Strand™ Rx is consists of absorbable seeding spacers and radionuclide brachytherapy sources spaced at prescribed distance and configuration within a sleeve (tube) made of absorbable suture material, stiffened, loaded into prostate seeding needles, packaged and then sterilized by Gamma sterilization method. The apparent activity of the seed ranges from 0.191 to 1.01 mCi that correspond air kerma strength value of 0.243 to 1.285 µGym2/h per seed. RAPID Strand™ RX is sterilized and ready to be use when shipped. RAPID Strand™ Rx should not be re-sterilized.
Intended Use
RAPID Strand™ Rx is a device specifically made in accordance with a medical specialist's written prescription, specified dose and design characteristics. It is intended to be use only for an individual named patient and 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.
Indications for Use
RAPID Strand ™ is indicated for permanent interstitial implantation of selected localized turnors which are low to moderate radiosensitivity. They may be used either as primary treatment (such as prostate cancer or unresectable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ may be indicated for use concurrent with or at the completion of other treatment modalities, such as external beam radiation therapy or chemotherapy.
Technological Characteristics
Section-F of this submission contains comparison of Similar and different characteristics compared to the predicate device (RAPID Strand™). All components used in the subject device have been previously cleared through 510(k) process. The differences shown in the table do not raise any issue about safety or efficacy of the subject device for its intended use. The labeling has been revised for clarity of device use and changes are non-significant. Please refer to Section-G for the Draft Copy of the proposed labeling. Please refer to the Section-C through Section-G for details.
Non-clinical Test Data
Non-clinical test data that includes design validation, process validation, bench test results and sterilization validation have been provided in the Section-H. Based on the results, one can conclude that changes made to the design and manufacturing processes do not raise any question about the safety and efficacy of the subject device for its intended use.
Conclusion:
Upon reviewing the safety and effectiveness information provided in this submission and comparing the design, intended use, indications for use, method of use and other technological characteristics, it can be concluded that the subject RAPID Strand™ Rx is substantially equivalent to the predicate RAPID Strand™ which was cleared under 510(k) # K030594 and K940632.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 3 0 2006
ONCURA, Inc. % Mr. Subhash Patel RA Consultant 43 Palmetto Way NORTH BRUNSWICK NJ 08902
Re: K063177
Trade/Device Name: RAPID StrandTM Rx Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: October 19, 2006 Received: October 23, 2006
Dear Mr. Patel:
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.
Image /page/2/Picture/10 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial of the Food and Drug Administration.
Protecting and Promoting Public Health
3
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 (240) 276-3150
or at its Internet address http://www.fda.gov/cdrfv/industry/support/index.html.
Sincerely yours,
Nancy Cbrogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): K063177
Device Name:
RAPID Strand™ Rx
Indications For Use:
RAPID Strand ™ Rx is indicated for permanent interstitial implantation of selected localized tumors, which are low to moderate radio sensitivity. They may be used either as primary tunnors, which are low to moderate racterestable tumors) or for treatment of residual disease after excision of the primary tumor.
RAPID Strand™ Rx may be indicated for use 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
Nancy C Brogdon
(Division Sign-Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number _