(80 days)
Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.
Implant Sciences Corp. Model HDR-4140 is a doubly-encapsulated 100 tterbium Brachytherapy Source. It consists of a plasma-welded titanium capsule containing solid radioactive 169Ytterbium pellets. The inner capsule is subsequently sealed in a stainless steel outer capsule that is attached to a cable to permit manipulation by the remote afterloading system.
The provided document is a 510(k) summary for the Implant Sciences Corp. Model HDR-4140, a brachytherapy source. This document focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance rather than presenting a detailed study with specific acceptance criteria and detailed performance metrics as one might find for a diagnostic or AI-driven device.
Therefore, much of the requested information (acceptance criteria, specific performance metrics, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this type of regulatory submission. The document primarily establishes the device's technical characteristics and intended use in comparison to existing, cleared devices.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided 510(k) summary. For a brachytherapy source, "acceptance criteria" generally refer to design specifications, material properties, safety standards (e.g., leak integrity, dose uniformity, mechanical integrity), and performance characteristics (e.g., source strength accuracy, stability). The document asserts that the device is "substantially equivalent" to predicate devices, implying that it meets similar performance and safety criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This a 510(k) for a physical medical device (a brachytherapy source) and does not involve a "test set" in the context of data anlaysis or algorithm evaluation. Device performance is typically assessed through engineering tests, simulations, and often, phantom studies, but not with "data provenance" in the sense of clinical datasets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as there is no "ground truth for a test set" in this context. The safety and effectiveness of the device are assessed based on its physical properties and adherence to manufacturing and performance standards, likely evaluated by internal and external engineers/physicists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable as there is no "test set" and no "adjudication method" in the context of expert review of clinical data.
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:
This is not applicable. The device is a physical brachytherapy source, not an AI or diagnostic imaging device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable. The device is a physical brachytherapy source, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As there is no "ground truth" in the typical sense of clinical data validation for an algorithm, this is not applicable. The "truth" here would relate to the physical and radiological properties of the source meeting design specifications and safety standards.
8. The sample size for the training set:
This information is not applicable as the device is not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as the device is not an AI algorithm requiring a training set.
Summary of what the document does provide regarding device characteristics and regulatory clearance:
- Device Name: Implant Sciences Corp. Model HDR-4140 169 Ytterbium Brachytherapy Source
- Intended Use: For the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative, or surface irradiation. Can be used as primary treatment for various anatomical sites (cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, breast, sarcomas, and intraoperative radiation therapy). It may be used concurrently with or following other interventions like external beam radiation therapy, hyperthermia, or chemotherapy.
- Technological Characteristics: It is a doubly-encapsulated 169 Ytterbium Brachytherapy Source (containing solid radioactive 169 Ytterbium pellets in a plasma-welded titanium capsule, sealed in a stainless steel outer capsule attached to a cable).
- Comparison to Predicate Devices: The key difference from predicate devices is the use of 169 Ytterbium photons instead of 192 Iridium. The 510(k) submission states that the device is "substantially equivalent" to predicate high dose rate brachytherapy sources, indicating it meets similar safety and effectiveness standards, albeit with a different radioisotope.
- Regulatory Status: Cleared under 510(k) K042864, dated January 6, 2005, indicating substantial equivalence to predicate devices.
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JAN - 6 2005
Attachment F 510(k) Summary
Section 807.92(a)
| (1) Submitter | Implant Sciences Corp.107 Audubon Road #5Wakefield, MA 01880 | ||||||
|---|---|---|---|---|---|---|---|
| Tel:781.246.0700Fax:781.246.1167 | Tel: | 781.246.0700 | Fax: | 781.246.1167 | |||
| Tel: | 781.246.0700 | ||||||
| Fax: | 781.246.1167 | ||||||
| Establishment Registration No.: 1226547 | |||||||
| Contact Person:John J. Munro IIIVice President, Brachytherapy Productse-mail: jmunro@implantsciences.com | Contact Person: | John J. Munro III | Vice President, Brachytherapy Products | e-mail: jmunro@implantsciences.com | |||
| Contact Person: | John J. Munro III | ||||||
| Vice President, Brachytherapy Products | |||||||
| e-mail: jmunro@implantsciences.com | |||||||
| (2) Device Name: | |||||||
| Classification Name: Radionuclide Brachytherapy Source (892.5730) (90 KXK) | |||||||
| Common or Usual Name: Brachytherapy Source Assembly | |||||||
| Proprietary Name: Implant Sciences Corp. Model HDR-4140 | |||||||
| (3) Legally Marketed Predicate Devices: |
Varian Medical Systems GammaMed 232, cleared under 510(k) number K030745 dated 12 March 2003, and
Nucletron Corp. Model 105.002, cleared under 510(k) number K953946 dated 13 August 1996, and
Alpha-Omega Services, Inc. Model CSN0010-192, cleared under 510(k) number K991571 dated 22 February 2000
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Description of Implant Sciences Corp. Model HDR-4140 169Y tterbium Brachytherapy Source: (4)
Implant Sciences Corp. Model HDR-4140 is a doubly-encapsulated 100 tterbium Brachytherapy Source. It consists of a plasma-welded titanium capsule containing solid radioactive 169Ytterbium pellets. The inner capsule is subsequently sealed in a stainless steel outer capsule that is attached to a cable to permit manipulation by the remote afterloading system. -
(5) Intended Use
The intended use of Implant Sciences Corp. Model HDR 4140 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
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Image /page/1/Picture/0 description: The image shows the logo for Implant Sciences Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic appears to be a stylized depiction of an ion implanter. The text "IMPLANT SCIENCES CORPORATION" is written in a bold, sans-serif font.
Technological Characteristics: (6)
Implant Sciences Corp. Model HDR-4140 109 tterbium Brachytherapy Source is similar to the predicate high dose rate brachytherapy sources, except it utilizes photons from 16°Ytterbium
instead of ''''Iridium used in the predicate devices.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 2005
Mr. John J. Munro III Vice President, Brachytherapy Products Implant Sciences Corporation 107 Audubon Road, #5 WAKEFIELD MA 01880-1246
Re: K042864 Trade/Device Name: Model HDR 4140 160 Ytterbium Brachytherapy Source Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: December 10, 2004 Received: December 13, 2004
Dear Mr. Munro:
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter natification. The FDA finding of substantial equivalence of your device to a legally premaince notificated with 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 11 you doche open 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/dsma/dsmamain.html
Sincerely yours,
Nancy C. Brogdon
Nancv 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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042864 510(k) Number: 1
Device Name: Implant Sciences Corp. Model HDR 4140 108 Ytterbium Brachytherapy Source
Indications for Use:
Implant Sciences Model HDR 4140 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct, brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy. This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia 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) | X |
|---|---|
| --------------------------------------- | --- |
Over-The-Counter Use
(Division Sinn Off) Division of Ronroductive and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.