(80 days)
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.
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.
The provided text describes the 510(k) Premarket Notification for the GRAC High Dose Rate (HDR) Remote Afterloading Catheter. Based on the given information, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Internal Friction Force | The device was subjected to testing for Internal Friction Force. The results "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." |
| Radiation Exposure | The device was subjected to testing for Radiation Exposure. The results "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." |
| Leak Test | The device was subjected to a Leak Test. The results "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." |
| Tensile Strength | The device was subjected to testing for Tensile Strength. The results "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." |
| Biocompatibility | The device was subjected to testing for Biocompatibility. The results "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." |
No specific quantitative or qualitative acceptance criteria thresholds are provided in the document. The document primarily states that the device 'was subjected to' these tests and the 'results provide reasonable assurance' of conformance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It only lists the types of tests performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the tests conducted were physical and material property tests of the device, not an evaluation of diagnostic or treatment performance requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the tests were physical and material property assessments of the device, not a clinical study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to the type of device and testing described. This is a physical medical device (catheter) for remote afterloading, and the testing focused on its material properties and functional integrity, not on its diagnostic efficacy or the impact of AI on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an algorithm or AI is not applicable here. The device is a physical catheter, and the testing focuses on its physical and functional properties, not on an algorithm's performance.
7. Type of Ground Truth Used
The "ground truth" for the tests described would be the physical and chemical specifications and performance standards for medical device components, such as acceptable ranges for internal friction, leak rates, tensile strength, and established biocompatibility standards. These are determined by engineering and material science principles, not expert consensus or pathology in a clinical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical device undergoing direct testing, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.
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MAY 27 1999
:
VII.1
:
510(k) Premarket Notification HDR Applicator Catheter COOK INCORPORATED
APPENDIX VII
SMDA SUMMARY
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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) RemoteAfterloading Catheter |
|---|---|---|
| Proposed Classification Name: | Remote Controlled Radionuclide ApplicatorSystem |
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
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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.
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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
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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
§ 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.