IMPLANT SCIENCES CORP. MODEL HDR 4454 by IMPLANT SCIENCES CORP.

Implant Sciences Model HDR 4454 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.

Device Description

Implant Sciences Corp. Model HDR-4454 is a singly-encapsulated 160 Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive feer thium pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device (Implant Sciences Corp. Model HDR-4454 169Ytterbium Brachytherapy Source), which is a regulatory submission to demonstrate substantial equivalence to a legally marketed predicate device. It does not describe an AI/ML medical device, and therefore the concepts of acceptance criteria, study design, ground truth, and human-in-the-loop performance as they relate to AI/ML devices are not applicable.

The document states that the device is "substantially equivalent" to a predicate device (Implant Sciences Corp. Model HDR-4140, K042864). This means that the FDA determined that the new device is as safe and effective as a legally marketed device.

Here's how the information provided aligns with your request, even though it's not an AI/ML device:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit): For a 510(k), the primary acceptance criterion is "substantial equivalence" to a predicate device in terms of intended use, technological characteristics, and safety/effectiveness. This is not expressed in a quantitative table for this type of device.
Reported Device Performance: The document highlights the technological characteristics of the new device (Model HDR-4454 169Ytterbium Brachytherapy Source) and compares them to the predicate (Model HDR-4140). The key performance aspect is that it utilizes photons from 169 Ytterbium, which is similar to the predicate. The FDA's letter states that they have determined the device is substantially equivalent, implying it met the regulatory performance requirements for this type of medical device submission.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (Summary from Submission)
Intended Use Equivalence: Same indications for use as predicate device.	"Intended use...is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation." This is consistent with brachytherapy sources.
Technological Characteristics Equivalence: Similar fundamental technology and operating principles.	"Similar to the predicate high dose rate brachytherapy source, Model HDR-4140 (K042864) that utilizes photons from 169 Ytterbium." Consists of a stainless steel capsule containing solid radioactive ytterbium pellets.
Safety and Effectiveness Equivalence: No new safety or effectiveness concerns raised compared to predicate.	No new concerns identified by FDA, resulting in a substantial equivalence determination.

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: For this type of device (a physical radioactive source), there isn't a "test set" in the sense of patient data or algorithm performance data. The evaluation for substantial equivalence relies on design specifications, material properties, manufacturing controls, and potentially non-clinical testing (e.g., radiation safety, dose uniformity, mechanical integrity), rather than empirical data from a "test set" of cases.

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: This device is not an AI/ML diagnostic tool, so there is no "ground truth" established by experts on a test set of medical images or patient data. The "ground truth" for a brachytherapy source relates to its physical and radio-pharmacological properties, which are verified through various physical and chemical tests, not clinical expert consensus.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: As there is no "test set" in the context of clinical data for an AI/ML device, there is no adjudication method.

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, so no MRMC study looking at human reader performance with or without AI assistance would have been conducted or is relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Engineering and Physical Standards: For a brachytherapy source, the "ground truth" would be established by validated engineering specifications, radiation physics principles, material science standards, and potentially preclinical testing results (e.g., dose distribution measurements, mechanical integrity tests).

8. The sample size for the training set

Not Applicable: This device is not an AI/ML device, so there is no "training set."

9. How the ground truth for the training set was established

Not Applicable: This device is not an AI/ML device, so there is no "training set" or corresponding ground truth.

In summary, this document is a regulatory approval for a physical medical device (a brachytherapy source) based on substantial equivalence to a predicate, not an AI/ML device requiring clinical performance studies with acceptance criteria, ground truth, or human performance evaluations.

Summary

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Image /page/0/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 is a black geometric shape with several vertical lines running through it. The company name is written in a bold, sans-serif font, with "IMPLANT SCIENCES" on the top line and "CORPORATION" on the bottom line.

MAR 2 3 2007

Section 5 510(k) Summ

Section 807.92(a)

Submitter (1) Implant Sciences Corp. 781.246.0700 Tel: 107 Audubon Road #5 Fax: 781.246.1167 Wakefield, MA 01880

Establishment Registration No .: 1226547

Contact Person: Matthew Hollows Director, Brachytherapy Products e-mail: mhollows@implantsciences.com

(2) Device Name:
Classification Name: Radionuclide Brachytherapy Source (892.5730) (90 KXK)

Common or Usual Name: Brachytherapy Source Assembly

Proprietarv Name: Implant Sciences Corp. Model HDR-4454

(3) Legally Marketed Predicate Devices: Implant Sciences Corp. Model HDR-4140, cleared under 510(k) number K042864 dated 06 January 2005
Description of Implant Sciences Corp. Model HDR-4454 1688 tterbium Brachytherapy Source: (4)

(5) Intended Use
The intended use of Implant Sciences Corp. Model HDR 4454 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
(6) Technological Characteristics:
Implant Sciences Corp. Model HDR-4454 188Ytterbium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source, Model HDR-4140 (K042864) that utilizes photons from 169 Ytterbium.

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Mr. Matthew Hollows Director of Brachytherapy Products Implant Sciences Corporation 107 Audobon Road #5 WAKEFIELD MA 01880

MAR 23 2007

Re: K070468

Trade/Device Name: Implant Sciences Corp. Model HDR-4454 169 Ytterbium Brachytherapy Source

Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: February 9, 2007 Received: February 21, 2007

Dear Mr. Hollows:

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.

Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, followed by the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The text "U.S. Food & Drug Administration" is arranged around the circle.

Protecting and Promoting Public Health

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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.

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. Brogdon

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:

K070468

Device Name: Implant Sciences Corp. Model HDR-4454 168Ytterbium Brachytherapy Source

Indications for Use:

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) OR

Over-The-Counter Use -----

David h. Slayton

(Optional Format 1-2-96)

(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070468

Regulation Number and Section

§ 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.