(80 days)
Not Found
No
The summary describes a physical catheter used for remote afterloading and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The device is a catheter used for the remote afterloading of a radiation source, indicating its role in a therapeutic radiation delivery system.
No
Explanation: The device is a catheter used for the remote afterloading of a radiation source, which is a therapeutic function. It is designed to deliver radiation, not to diagnose a condition.
No
The device description clearly describes a physical catheter, which is a hardware component. The performance studies also focus on physical properties and testing of the catheter.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "remote afterloading of a radiation source" and is used with a specific afterloader system. This describes a therapeutic procedure involving the delivery of radiation to a patient, not the examination of specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a catheter used for delivering a radiation source, which is consistent with a therapeutic device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
Therefore, this device falls under the category of a therapeutic medical device, specifically used in brachytherapy, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is intended for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.
Product codes (comma separated list FDA assigned to the subject device)
90 JAQ
Device Description
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 5.6 French , 129cm long, single lumen catheter. The distal end of the catheter is closed. The outside diameter of the shaft has placement markings to facilitate accurate pre-treatment positioning of the catheter. The catheter is compatible with the GammaMed 12i Remote High Dose Rate Afterloader supplied by Frank Barker Associates, of Tuwaco, New Jersey.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Internal Friction Force
- Radiation Exposure
- Leak Test
- Tensile Strength
- Biocompatibility
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.
0
MAY 27 1999
:
VII.1
:
510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED
APPENDIX VII
SMDA SUMMARY
1
510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED
Safety and Effectiveness Information
April Lavender, RAC Submitted By: Vice President, Regulatory Affairs COOK INCORPORATED 925 South Curry Pike P.O. Box 489 Bloomington, IN 47402 (812) 339-2235
| Device: | Trade Name: | GRAC High Dose Rate (HDR) Remote
Afterloading Catheter |
|-------------------------------|-------------|-----------------------------------------------------------|
| Proposed Classification Name: | | Remote Controlled Radionuclide Applicator
System |
Intended Use:
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is intended for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.
Predicate Devices:
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar in terms of intended use, materials of construction, and technological characteristics to predicate devices reviewed as remote afterloading catheters.
Device Description
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 5.6 French , 129cm long, single lumen catheter. The distal end of the catheter is closed. The outside diameter of the shaft has placement markings to facilitate accurate pre-treatment positioning of the catheter. The catheter is compatible with the GammaMed 12i Remote High Dose Rate Afterloader supplied by Frank Barker Associates, of Tuwaco, New Jersey.
Substantial Equivalence
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is similar to other Cook Incorporated remote afterloading catheters which were found substantially equivalent under
2
510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED
510(k) #D.C. K945383 and D.C. K981886. The similar indications for use and technological characteristics of the GRAC High Dose Rate (HDR) Remote Afterloading Catheter as compared to the predicate devices supports a determination of substantial equivalency.
Test Data
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests include:
- Internal Friction Force જુન
- 参 Radiation Exposure
- જુન Leak Test
- 参 Tensile Strength
- 必 Biocompatibility
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator.
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 7 1000
April Lavender Vice President, Regulatory Affairs Cook. Inc. 925 South Curry Pike Bloomington, IN 47402
Re: K990753
GRAC High Dose Rate (HDR) Remote Afterloading Catheter Dated: March 4, 1999 Received: March 8, 1999 Regulatory class: II 21 CFR 892.5700/Procode: 90 JAQ
Dear Ms. Lavender:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 manical Device Amendments, or to devices that have been redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
BART David S. Schulte, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED
510(k) Number (if known): _ K 9 90 7 53
High Dose Rate (HDR) Remote Afterloading Catheter Device Name:
Indications for Use:
Used for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﮐﮯ Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use
Daniel A. Severson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological D 510(k) Number