GENETRA ™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.

Device Description

GENETRA ™ utilizes Pd-103 as the radionuclide for brachytherapy. GENETRA™ exists in the form of a coiled rhodium wire. The rhodium matrix also provides the radiopacity of the device. GENETRA™ is a naturally sealed source in the form of a wire. GENETRA™ is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave. GENETRA™ will be manufactured, labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures. The sources are delivered using a 19 gauge needle and stylet.

AI/ML Overview

The provided document describes the GENETRA™ brachytherapy radionuclide source and its submission for 510(k) clearance. However, it does not contain a detailed study report with specific acceptance criteria and performance data for a device in the context of diagnostic AI or image analysis.

The document focuses on comparing GENETRA™ to its predicate device (RadioMed™ Source K001070) based on shared technological characteristics and compliance with manufacturing and safety standards. The "Performance Testing" section lists categories of tests but provides no numerical acceptance criteria or performance results.

Therefore, I cannot directly answer most of your detailed questions regarding acceptance criteria, study design, sample sizes, expert qualifications, or comparative effectiveness with AI. The device described is a medical implant (radioactive source), not a diagnostic AI or imaging device that would typically involve such studies.

Here's a breakdown of what can be extracted or inferred from the provided text, addressing your points where possible, and noting where information is missing:

Acceptance Criteria and Device Performance for GENETRA™

The document does not explicitly state numerical acceptance criteria or specific performance results for the GENETRA™ device in the format typically used for diagnostic or AI-based devices. Instead, performance is framed in terms of meeting established industry standards for radioactive sources and being identical in fundamental design and characteristics to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Category	Acceptance Criteria (Inferred from standards and predicate comparison)	Reported Device Performance (Inferred from "Summary of standards achieved" and "identical to predicate")
Material Composition	Identical to predicate RadioMed™ Source (rhodium matrix). Radionuclide: Palladium - 103, identical to predicate. Packaging: modified from original stainless steel cartridge to utilize a glass barrel, but fundamentally similar.	GENETRA™ uses rhodium as did the predicate RadioMed™ Source. Radionuclide for GENETRA™ is Palladium - 103, which is the same as the predicate.
Energy Emission	Identical to predicate RadioMed™ Source (20-23 keV x-rays).	Energy emitted for GENETRA™ and the RadioMed™ Source is identical: 20-23 keV x-rays.
Physical Design	Identical to predicate RadioMed™ Source. "Sealed source in the form of a wire from which to deliver a therapeutic dosage of radioactive energy."	The design of the predicate RadioMed™ Source is identical to GENETRA™.
Sterilization	To be sterilized by the end-user in accordance with a validated sterilization process (exposure to steam autoclave). Complies with AAMI Standard 11134-1994 (Recommended practice for Steam Autoclave).	Device is packaged non-sterile, single use, and is to be sterilized by the end user via steam autoclave. Compliance with AAMI 11134-1994 is listed.
Manufacturing Quality	Compliance with FDA QSR 21 CFR Part 820 Good Manufacturing Practices. Devices inspected to assure compliance to specifications and tested in accordance with Standard Operating Procedures.	Manufactured, labeled, and packaged under GMP controls. Inspected to assure compliance to specifications. Tested in accordance with Standard Operating Procedures.
Biological Evaluation	Compliance with ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices.	Compliance with ISO 10993-1 1992 (E) listed.
Sealed Source Testing	Compliance with ANSI N43.6-1997 (Classification of sealed radioactive sources), ANSI N44.1-1973 (Integrity and Test Specifications for selected Brachytherapy Sources), ANSI N44.2-1973 (Leak testing radioactive brachytherapy sources), and ISO 9978: 1992(E) ("Radiation protection - Sealed radioactive sources - Leakage test methods").	Compliance with ANSI N43.6-1997, ANSI N44.1-1973, ANSI N44.2-1973, and ISO 9978: 1992(E) listed under "Summary of standards achieved." "Sealed Source Testing" is one of the four performance categories.
Needle Gauge	Delivery through a 19 gauge needle and stylet. (Predicate uses 17 or 18 gauge).	GENETRA™ sources are delivered using a 19 gauge needle and stylet. (This is a design modification from the predicate, but is a stated characteristic of GENETRA™).
Activity Range	0.1 to 5.0 mCi per centimeter length.	GENETRA™ produced with activities from 0.1 to 5.0 mCi per centimeter length.
Radiation Energy	No specific numerical acceptance criteria provided in the text beyond "identical to predicate".	"Radiation Energy" is listed as a performance category. The energy emitted is 20-23 keV x-rays, identical to the predicate.
Source Strength Measurement: Calibration and Calibration Accuracy	No specific numerical acceptance criteria provided in the text.	"Source Strength Measurement: Calibration and Calibration Accuracy" is listed as a performance category. No specific results are reported.
Dose Comparison	No specific numerical acceptance criteria provided in the text.	"Dose Comparison" is listed as a performance category. No specific results are reported, but given the identical radionuclide and energy, the dose characteristics are implied to be clinically comparable to the predicate.

Missing Information (Not applicable or not typically included for this type of device)

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set of clinical cases or patient data is mentioned as this is a device clearance for a radiation source based on substantial equivalence and engineering standards, not a clinical trial of its efficacy with patient outcomes in a diagnostic context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a clinical diagnosis or image interpretation is not relevant for this type of device submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 or diagnostic imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for a device quality and safety submission based on substantial equivalence. The "ground truth" here is compliance with engineering, manufacturing, and safety standards for radioactive sources.
The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

{0}------------------------------------------------

KDI 3660

GENETRA ™

Special 510(K) Submission

RadioMed Corporation November 2, 2001

DEC 0 5 2001

Section F

510k Summary

Sponsor Name

RadioMed Corporation One Industrial Way Tyngsboro, Massachusetts 01879-1400

Telephone: (978) 649-0300 voice (978) 649-0333 fax

Contact Individual: Gordon Roberts

1. Device Name

Proprietary Name:	GENETRA™
Common/Usual Name:	Brachytherapy Radionuclide Source
Classification Name:	Brachytherapy Radionuclide

1. Identification of Predicate or Legally Marketed Device The predicate device for GENETRA™ is the RadioMed™ Source K001070.
1. Device Description

GENETRA™ is packaged non-sterile, single use, and is to be sterilized by the end user in accordance with a validated sterilization process. Sterilization is accomplished by exposure to steam autoclave.

GENETRA™ will be manufactured, labeled and packaged under GMP controls. Upon completion of the manufacturing and assembly process the device will be inspected to assure compliance to specifications. The devices will be tested in accordance with Standard Operating Procedures.

The sources are delivered using a 19 gauge needle and stylet. Currently marketed Brachytherapy seeds are delivered using a 17 or 18 gauge needle and stylet.

{1}------------------------------------------------

5. Intended Use

The intended use and indications for use of the modified device as described in its labeling have not changed.
GENETRA™ with activities from 0.1 to 5.0 mCi per centimeter length is indicated for temporary or permanent interstitial implantation or surface application to treat selected localized tumors. They can be used as either primary treatment or as treatment for residual disease after excision of primary or recurrent turnors. GENETRA may be used concurrently with or following treatment with other interventions, such as external beam therapy, hyperthermia, or chemotherapy. Tumors of the head, neck, lung, pancreas, prostate and other accessible tumors are commonly treated.
1. Comparison of Technological Characteristics
  The fundamental scientific technology of the modified device has not changed.

RadioMed™ Source Predicate Device:

K001070 510(k) Number:

The design of the predicate RadioMed 104 Source is identical to GENETRA™ . This is a sealed source in the form of a wire from which to deliver a therapeutic dosage of radioactive energy.

The energy emitted for GENETRA™ and the RadioMed™ Source is identical: 20-23 keV x-rays.

The materials that make up the components of the predicate RadioMed™ Source and GENETRA™ are identical. The packaging has been modified to utilize a glass barrel with the original stainless steel cartridge. GENETRA™ uses rhodium as did the RadioMed™ Source.

The radionuclide for GENETRA™ is Palladium - 103, which is the same as the radionuclide used for the predicate RadioMed™ Source.

The delivery of the predicate RadioMed TM Source is through a 17 or 18-gauge needle and stylet.

{2}------------------------------------------------

7. Performance Testing

Summary of standards achieved:

FDA QSR 21 CFR Part 820 Good Manufacturing Practices ISO 10993-1 1992 (E) Biological Evaluation of Medical Devices ANSI N43.6-1997: Classification of sealed radioactive sources ANSI N44.1-1973 Integrity and Test Specifications for selected Brachytherapy Sources ANSI N44.2-1973 Leak testing radioactive brachytherapy sources ISO 9978: 1992(E) "Radiation protection - Sealed radioactive sources - Leakage test methods". AAMI Standard 11134-1994 Recommended practice for Steam Autoclave

The "performance" of GENETRA™ is subdivided into four categories

1. Radiation Energy
1. Source Strength Measurement: Calibration and Calibration Accuracy
1. Dose Comparison
1. Sealed Source Testing

{3}------------------------------------------------

Image /page/3/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 an abstract symbol that resembles a stylized caduceus, which is a traditional symbol of medicine and healthcare. The symbol consists of a staff with two snakes coiled around it, and a pair of wings at the top.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 0 5 2001

Mr. Gordon Roberts Quality Assurance and Regulatory Affairs Manager RadioMed Corporation One Industrial Way Tyngsboro, MA 01879

Re: K013660

Trade/Device Name: GENETRA™ Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: November 2, 2001

Received: November 6, 2001

Dear Mr. Roberts:

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 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

{4}------------------------------------------------

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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this 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" (21 CFR Part 807.97). 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. Snogdon

Nancv C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

K013660

RadioMed Corporation November 2, 2001

GENETRA Special 510(K) Submission

Section E

Indications For Use

indications For USE
GENETRA ™ with activities from 0.1 to 5.0 mCi per centimet selected lasted for temporary of GENETRA" with activities from 0.1 to 5.0 met per called bocalized tocalized tumors. They can be
permanent interstitial implantation or surface application of primary or permanent interstitudi implanation of surface uppressional disease after excision of primary of used ellifer as the primary treatment of as a career may with or following treatment with other recurrent unfors. micil ventions, such as external secure assible turnors are commonly treated.

Prescription Use

Nancy Broglon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K013660

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.