(49 days)
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The Mick HDR IORT Shielded Applicator is designed to act as such a device.
This 510(k) submission for the Mick HDR IORT Shielded Applicator does not contain a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., involving AI performance, human reader improvement, or detailed statistical analysis of performance metrics).
Instead, this document is a premarket notification (510(k)) based on substantial equivalence to previously approved devices. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed predicate devices, and therefore does not require a new premarket approval (PMA). The "study" here is essentially the comparison to predicate devices, demonstrating that the new device shares similar design, materials, intended use, and performance characteristics, and introduces no new issues of safety or effectiveness.
Here's how to interpret the provided information in the context of your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission based on substantial equivalence is that the device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. This is not quantified with specific performance metrics in the way you might see for an AI algorithm study.
- Reported Device Performance: The document states:
- "This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices."
- "No new issues of safety or effectiveness are introduced by using this device."
- The device is designed to function as "accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer" and provides "a reproducible and predictable geometry for positioning of the radioactive source under remote control."
Since this is a substantial equivalence determination and not a performance study comparing the device to specific clinical outcomes or statistical thresholds, a table like the one you requested cannot be populated from this document. The performance is implicitly "equivalent to predicate devices."
2. Sample size used for the test set and the data provenance
- N/A. No "test set" in the sense of a dataset for evaluating an AI algorithm or a clinical trial for performance metrics is described. The evaluation is based on engineering design, material equivalence, and intended use comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth for a test set is not applicable here as there is no such test set or performance study described. The "ground truth" for this submission is that predicate devices are already considered safe and effective by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is described because there is no test set or performance study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This document describes a medical device (a radionuclide applicator system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the established safety and effectiveness of the predicate devices, as determined by their prior FDA clearance (K-numbers). The current device's safety and effectiveness are established by demonstrating its substantial equivalence to these predicates in terms of design, materials, and intended use.
8. The sample size for the training set
- N/A. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- N/A. Not applicable for the reasons stated above.
In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not involve performance studies or evaluations in the manner typically associated with AI or diagnostic imaging devices where your requested criteria would be relevant. The "study" is the comparison to predicate devices.
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0C1 ] 7 2005
K05235/
Summary of Safety and Effectiveness Compliance with 513 (i) of the Federal Food, Drug and Cosmetic Act
May 6, 2005
General Provisions 1.
Remote Controlled Radionuclide Applicator System Common/Usual Name:
Mick HDR IORT Shielded Applicator Proprietary Name:
Applicant Name and Address:
Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue Mount Vernon. New York 10550
Name of Predicate Devices: 2.
(1)
| Device | Manufacturer | K Number |
|---|---|---|
| Mick H.A.M Applicator | Mick Radio-Nuclear Instruments,Inc. | K961601 |
| Mick Shielded Vaginal Applicator | Mick Radio-Nuclear Instruments,Inc | K001544 |
| Mammo Site RTS | Proxima Therapuetics, Inc. | K011690 & K030558 |
Any statement made in conjunction with this submission regarding substantial equivalence to any other product only relates to whether the product can be lawfully marketed without pre-market approval or reclassification and is not to be interpreted as an admission or used as evidence in patent infringement litigation. As the Commissioner of the FDA has indicated, " ... a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42,520 et seg. (1977).
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Classification 3.
:
This device is classified as a class II device according to 21 CFR 892.5700 .
Performance Standards 4.
Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
Intended Use and Device Description 5.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below.
| Device | Manufacturer | K Number |
|---|---|---|
| Mick H.A.M Applicataor | Mick Radio-Nuclear Instruments, Inc. | K961601 |
| Mick Shielded VaginalApplicator | Mick Radio-Nuclear Instruments, Inc. | K001544 |
| Mammo Site RTS | Proxima Therapuetics, Inc. | K011690 & K030558 |
The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The Mick HDR IORT Shielded Applicator is designed to act as such a device.
Biocompatibility 6.
No new issues of biocompatibility are raised with regard to this device.
Summary of Substantial Equivalence 7.
This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three wavy lines, which represent the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Felix Mick President Mick Radio-Nuclear Instruments, Inc. 521 Homestead Avenue
MOUNT VERNON NY 10550
Re: K052351 Trade/Device Name: MICK HDR IORT Shielded Applicator Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: JAQ Dated: August 26, 2005 Received: August 30, 2005
Dear Mr. Mick:
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.
OCT 17 2005
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.
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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. Hogdon
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
510(k) Number: To be assigned
Device Name: MICK HDR IORT Shielded Applicator
Indications for Use:
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been I he MOR TIDE TOR "Steessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.
Concurrence of CDRH. Office of Device Evaluation (ODE)
Prescription Use: 6
()r
(Per 21 CFR 801.109) Over-The Counter Use: __
- (Ter 21 CFR 801.109)
Nancy Hodgson
(Division Sign-Off)
(Division Sign-Off) (Division of Reproductive, Abdominal, and Radiological Devices
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.