(71 days)
IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.
The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).
The provided text is a 510(k) Summary for the IsoRay, Inc. Lawrence CSERION Model CS-1, a brachytherapy source. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets is not available in this document.
The document states that the device is "substantially equivalent" to predicate devices based on a comparison of parameters. The "Comparison Chart" on page 0 outlines these parameters. This comparison is the "study" demonstrating the device meets the criteria for substantial equivalence, implying that if the new device's parameters are similar enough to an already approved device, it is considered safe and effective.
Here's a breakdown of what is provided, framed in terms of the closest available information to your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it presents a "Comparison Chart" to demonstrate substantial equivalence to predicate devices. The "acceptance criterion" here is essentially that the new device's parameters are comparable to those of already cleared devices.
| Parameters for Evaluating Substantial Equivalence | IsoRay, Inc. Lawrence CSERION (Reported Performance) | Predicate Device(s) (Reference) |
|---|---|---|
| Indications for Use | Malignant Disease | Same |
| Radionuclide | Cs-131 | Same for K924261, I-125 for K914281, Pd-103 for K010283 |
| Half-Life (days) | 9.69 | Same for K924261, 59.4 for K914281, 17.0 for K010283 |
| Principle Energies (keV) | 29.5, 29.8, 33.6 | Same for K924261, 27.4, 31.4, 35.5 for K914281, 20-22 for K010283 |
| Patient-Contacting Capsule: | Welded Titanium | Same |
| Nominal External Length (mm) | 4.5 | Same |
| Nominal External Diameter (mm) | 0.8 | Same |
| Radiographic Marker | Gold Wire | Various (Predicate: Silver Rod, Lead Piece) |
| Apparent Activity Range (mCi) | 0.20 to 50.0 | 0.1 to 100 (Predicate: 5.0 to 40, 0.1 to 10) |
| External Contamination (uCi) | < 0.005 uCi | Same |
| Implantation/Application Method | Needles, Applicators, Tubing, Catheters, Expanders, etc. | Same |
Regarding the other requested points:
- 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. This is not a study assessing performance on a dataset of patient data. It's a comparison of device specifications.
- 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. Ground truth for a clinical dataset is not relevant to a device specification comparison.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 device is a brachytherapy seed, not an AI software.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a brachytherapy seed, not an algorithm.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established characteristics and performance of the predicate device(s) as cleared by the FDA.
- 8. The sample size for the training set: Not applicable. There is no AI model or training set involved.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, the provided document is a 510(k) submission for a medical device (brachytherapy seeds) that seeks to demonstrate substantial equivalence to already approved devices. It is not a document detailing a performance study with acceptance criteria for an AI or diagnostic device. The "study" here is the comparison of technical specifications against predicate devices.
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Image /page/0/Picture/0 description: The image shows the logo for ISORAY INC. The logo is in black and white, with the company name in a bold, sans-serif font. There are two horizontal lines under the company name. The logo is simple and professional.
510(k) Summary
Image /page/0/Picture/3 description: The image shows a handwritten number sequence, "(030162", followed by the date "MAR 2 8 2003" printed in a bold, sans-serif font. The number sequence appears to be written with a thick marker, and the date is printed in all capital letters. The date indicates that the image was created or related to something that happened on March 28, 2003. The combination of handwritten numbers and a printed date suggests that this image could be from a document, record, or label.
| Summary Date: | January 13, 2003 |
|---|---|
| Submitter Information: | IsoRay, Inc.350 Hills Street, Suite 106Richland, WA 99352 |
| Phone: 509-375-1202FAX: 509-372-5153 | |
| Contact Person/Email: | David J. Swanberg, COOEmail: DJSwanberg@msn.com |
| Trade Name: | Lawrence CSERION Model CS-1 |
| Common Name: | Brachytherapy Sources (Seeds) |
| Classification Name: | Class II, 90-KXK, Brachytherapy, Radionuclide |
| Primary Predicate Device: | K924261 Radioactive Cesium-131 Seeds/Sources |
| Device Description: | The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindricalsealed source which contains the low energy gamma (X-ray) emittingradionuclide, cesium-131, adsorbed onto an internal inorganic substrate. Thenominal external seed dimensions (4.5 mm length and 0.8 mm diameter) andpatient-contacting material (titanium) are identical to predicate device(s). |
| Intended Use: | IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment ofmalignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may beused in surface, interstitial, and intracavitary applications for tumors with knownradiosensitivity. The seeds may be used as a primary treatment or in conjunctionwith other treatment modalities, such as external beam radiation therapy,chemotherapy or as treatment for residual disease after excision of primarytumors. |
Comparison Chart:
| Parameters for Evaluating | IsoRay, Inc. | Predicate Device(s) | |||
|---|---|---|---|---|---|
| Substantial Equivalence | Lawrence CSERION | K924261 | K914281 | K010283 | |
| Indications for Use | Malignant Disease | Same | Same | Same | |
| Radionuclide | Cs-131 | Same | I-125 | Pd-103 | |
| Half-Life (days) | 9.69 | Same | 59.4 | 17.0 | |
| Principle Energies (keV) | 29.5. 29.8. 33.6 | Same | 27.4, 31.4, 35.5 | 20-22 | |
| Patient-Contacting Capsule: | Welded Titanium | Same | Same | Same | |
| Nominal External Length (mm) | 4.5 | Same | Same | Same | |
| Nominal External Diameter (mm) | 0.8 | Same | Same | Same | |
| Radiographic Marker | Gold Wire | Various | Silver Rod | Lead Piece | |
| Apparent Activity Range (mCi) | 0.20 to 50.0 | 0.1 to 100 | 5.0 to 40 | 0.1 to 10 | |
| External Contamination (uCi) | < 0.005 uCi | Same | Same | Same | |
| Implantation/Application Method | Needles, Applicators, TubingCatheters, Expanders, etc. | Same | Same | Same |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of human figures, rendered in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David J. Swanberg Chief Operations Officer IsoRay, Inc. 350 Hills Street, Suite 106 RICHLAND WA 99352
Re: K030162
MAR 2 8 2003
Trade/Device Name: Lawrence CSERION Model CS-1 Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: January 13, 2003 Received: January 16, 2003
Dear Mr. Swanberg:
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.
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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 vours.
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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Image /page/3/Picture/0 description: The image shows the logo for IsoRay Inc. The logo is in black and white, with the words "IsoRay" in large, bold letters. The word "INC." is in smaller letters to the right of "IsoRay". There are two horizontal lines under the text.
Statement of Indications for Use D.
| Applicant: | IsoRay, Inc. |
|---|---|
| 510(k) Number: | K030162 |
| Device Name: | Lawrence CSERION Model CS-1 |
Indications For Use (Page 1 of _1 ):
IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.
DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
or Over-The Counter Use
(Per 21 CFR 801.109)
David Ingram
Division of Reproductive, and Radiological Devi 510(k) Numbe
Page 6 of 71
Confidential Until SE Determination
§ 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.