(127 days)
The ISOAID Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.
Here's an analysis of the provided text regarding the acceptance criteria and study for the IsoAid Palladium Brachytherapy Seeds:
Based on the provided documents, it's evident that this 510(k) submission is for a medical device (IsoAid Palladium Brachytherapy Seeds) and not an AI/ML powered device. Therefore, the questions related to AI/ML specific aspects like AI performance, human readers with/without AI assistance, standalone algorithm performance, training set, and AI-specific ground truth methods are not applicable.
The approval for this device is based on substantial equivalence to a predicate device, the TheraSeed Palladium-103 Model 200 Implant, rather than a clinical study proving its performance against acceptance criteria in the context of an AI/ML diagnostic or prognostic tool.
Here's a breakdown of the requested information based on the provided text, focusing on what is applicable to a substantial equivalence submission for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (from Predicate Device) | Reported Device Performance (IsoAid Palladium Brachytherapy Seeds) | Basis for Acceptance |
|---|---|---|---|
| Indications for Use | Brachytherapy for localized tumors | Brachytherapy for localized tumors | "Same" as predicate (Substantial Equivalence) |
| Capsule | Titanium | Titanium | "Same" as predicate (Substantial Equivalence) |
| Capsule Sealing Method | Laser Weld | Laser Weld | "Same" as predicate (Substantial Equivalence) |
| Half-Life | 17.0 days | 17.0 days | "Same" as predicate (Substantial Equivalence) |
| Length | 4.5 mm | 4.5 mm | "Same" as predicate (Substantial Equivalence) |
| Outside Diameter | 0.8 mm | 0.8 mm | "Same" as predicate (Substantial Equivalence) |
| Application Method | Through an 18 gauge needle | Through an 18 gauge needle | "Same" as predicate (Substantial Equivalence) |
| Apparent Activity | 0.10 to 5.0 mCi | 0.10 to 5.0 mCi | "Same" as predicate (Substantial Equivalence) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm requiring a test set for performance evaluation. The "study" is a comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm. The "ground truth" for this submission are the established specifications and safety profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is a substantial equivalence submission for a physical device, not an AI/ML algorithm.
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
Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used here is the performance and safety profile of the legally marketed predicate device (TheraSeed Palladium-103 Model 200 Implant) as accepted by the FDA. The submission demonstrates that the new device has identical specifications and intended use as the predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
Summary of the Study (Substantial Equivalence):
The "study" or evidence provided to the FDA for the IsoAid Palladium Brachytherapy Seeds is a comparison against a legally marketed predicate device, the TheraSeed Palladium-103 Model 200 Implant (K010283). The applicant asserts that the IsoAid device has identical specifications and intended use to the predicate device. The comparative data (presented in the table) directly shows that critical parameters such as material (titanium capsule), manufacturing method (laser weld), physical dimensions (length, diameter), radioactive properties (half-life, apparent activity), and application method are all the "same" as the predicate.
The acceptance criteria are effectively the specifications and previously accepted safety/efficacy profile of the predicate device. The IsoAid device "meets" these criteria by being demonstrably identical across all relevant engineering and performance characteristics. The FDA's issuance of a substantial equivalence determination signifies that they agreed the new device is as safe and effective as the predicate device, without requiring new clinical trials due to the direct equivalence.
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APR - 8 2004
Kø33 77ø
510(k) SUMMARY
(as required by 807.92(c))
| Submitter of 510(k): | IsoAid, LLC7824 Clark Moody Blvd.Port Richey, FL 34668Phone: 727-815-3262Fax: 727-815-1972 |
|---|---|
| Contact Person: | Max Taghizadeh |
| Date of Summary: | October 31, 2003 |
| Trade Name: | IsoAid Palladium Brachytherapy Seeds |
| Classification: | Class II, Classification number is 90 KXK |
| Classification Name: | Brachytherapy, Radionuclide |
| Predicate Device: | TheraSeed Palladium-103 Model 200 Implant |
| Device Description/Comparison: | The IsoAid palladium-103 seeds are sphericalsealed sources of palladium-103. The outer capsuleof the source is sealed titanium. The specificationsfor the IsoAid device are the same as for thepredicate. |
| Intended Use: | The ISOAID Palladium Brachytherapy Seeds isintended for the treatment of selected localizedtumors. The devices are implanted as a source ofnuclear radiation for therapy. |
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Image /page/1/Picture/0 description: The image shows a handwritten sequence of characters, "K033779", above the words "Comparison Chart". The characters are written in a cursive style, and the words "Comparison Chart" are underlined. The text is black against a white background.
| IsoAid Brachytherapy Seeds | TheraSeed Palladium-103Model 200 | |
|---|---|---|
| 510(k) Number | To Be Determined | K010283 |
| Indications for Use | Brachytherapy for localized tumors | Same |
| Capsule | Titanium | Same |
| Capsule Sealing Method | Laser Weld | Same |
| Half-Life | 17.0 days | Same |
| Length | 4.5 mm | Same |
| Outside Diameter | 0.8 mm | Same |
| Application Method | Through an 18 gauge needle | Same |
| Apparent Activity | 0.10 to 5.0 mCi | Same |
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Image /page/2/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Mr. Max Taghizadeh President IsoAid, LLC 7824 Clark Moody Boulevard PORT RICHEY FL 34668
Re: K033770
Trade/Device Name: IsoAid Advantage Pd-103 Regulation Number: 21 CFR $892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 12, 2004 Received: March 15, 2004
Dear Mr. Taghizadeh:
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 (PMA), it may be subject to 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 CHR 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 the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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. Brygdon
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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510 (k) Number (if known): K433270
Device Name:
Advantage™ Pd-103
Indications For Use:
The IsoAid Palladium Brachytherapy Secd is intended for the treatment of selected localized The ISOAN I anathum Brachyalerapy became of nuclear radiation for therapy.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109) ાર
()ver the Counter Use
(Optional Format 1-2-96)
Nancy C Broadon
(Division Sign-Off Division of Reproductive, A and Radiological Devices 510(k) Number _
§ 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.