(164 days)
The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.
The IsoAid I-125 Radioactive Seed Localization Needle [IA-RSLN] is a pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed [K011205]. The needle tip is occluded with bone wax to contain the contents prior to implant. The iodine seed is loaded loose or stranded and is provided with or without trailing spacers. The stainless steel needles are provided in lengths: 5cm, 7cm, and 12cm. The device is used to facilitate the introduction of the radionuclide seed into the suspicious tissue. The seed is used singly as a point-source for localization rather than for therapeutic use as in brachytherapy. The device is packaged and labeled and EtO sterilized.
The provided text describes a 510(k) premarket notification for the IsoAid I-125 Radioactive Seed Localization Needle (IA-RSLN). This submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new performance criteria or provide a study proving the device meets specific acceptance criteria in the sense of a new clinical trial.
Therefore, the document does not contain the detailed information typically found in a study designed to prove a device meets acceptance criteria for an AI/CADe system. Specifically, there is no information on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or the number/qualifications of experts for ground truth.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Types of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets, or how ground truth for training sets was established.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway.
What is provided in the document regarding "acceptance" and "proof":
The "acceptance criteria" here refers to the criteria for demonstrating substantial equivalence to a predicate device, as required for a 510(k) submission. The "study that proves the device meets the acceptance criteria" is the 510(k) summary itself, which argues for this substantial equivalence based on technological characteristics and intended use.
Here's a breakdown of the relevant information provided, interpreted within the context of a 510(k) submission:
| Category | Information from the Document |
|---|---|
| 1. Acceptance Criteria and Reported Device Performance | Acceptance Criteria (for 510(k) Substantial Equivalence): The document implies that the "acceptance criteria" are met by demonstrating that the IsoAid I-125 Radioactive Seed Localization Needle (IA-RSLN) has the "same intended use and fundamental scientific technology" as a legally marketed predicate device, and is "safe and effective for its intended use." This involves: - Same Indications for Use: Localization of suspicious tissues (non-palpable lesions) for excision with radioactive seeds. - Similar Device Description: Pre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed. - Compliance with Standards: The device "meets ISO 2919, ISO 9978, and Type A packaging requirements." These are international standards related to radionuclide products and packaging. Reported Device Performance: The document does not provide a table of quantitative performance metrics (e.g., sensitivity, specificity, accuracy) because it is not a clinical trial report. Instead, performance is implied by the equivalence to the predicate and compliance with technical standards. The conclusion states: "Based on the above, IsoAid LLC believes the RSLN device is substantially equivalent to the predicate device, and is safe and effective for its intended use." |
| 2. Sample size and Data Provenance | Not applicable. This document is a regulatory submission for substantial equivalence based on device design and comparison to a predicate, not a study evaluating human or AI performance on a test set. Therefore, there are no specific "sample sizes" (e.g., number of image cases) or "data provenance" (country of origin, retrospective/prospective) in the context of a performance study. |
| 3. Number of experts for ground truth & qualifications | Not applicable. Ground truth generation by experts is relevant for studies evaluating diagnostic performance (e.g., of an AI algorithm or human reader). This document describes a medical device (a radioactive seed and needle), not a diagnostic algorithm. |
| 4. Adjudication method | Not applicable. Adjudication methods are used to establish a definitive ground truth in diagnostic performance studies. This document is a 510(k) submission for a physical medical device. |
| 5. MRMC comparative effectiveness study | Not applicable. This type of study assesses the impact of AI assistance on human reader performance. The device described, the I-125 Radioactive Seed Localization Needle, is a physical medical device used for localization and excision, not an AI or CADe system that assists human interpretation of medical images. |
| 6. Standalone performance | Not applicable. Standalone performance refers to the algorithm's performance without human intervention. This is a physical medical device, not an algorithm. |
| 7. Type of ground truth used | Not applicable. "Ground truth" in the context of performance studies typically refers to a definitive diagnosis or outcome used to evaluate the accuracy of a diagnostic tool or interpretation. For this device, the "truth" is established by its physical and radioactive characteristics, its intended use matching the predicate, and its compliance with relevant BSI and ISO standards (ISO 2919, ISO 9978, Type A packaging). |
| 8. Sample size for training set | Not applicable. This refers to machine learning models. This document describes a physical medical device. |
| 9. How ground truth for training set was established | Not applicable. This refers to machine learning models. This document describes a physical medical device. |
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a wavy line below them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2014
IsoAid, LLC % Mary Ann Greenawalt Regulatory & Quality Director 7824 Clark Moody Blvd. PORT RICHEY FL 34668
Re: K141701 Trade/Device Name: I-125 Radioactive Seed And Localization Needle Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: October 29, 2014 Received: October 30, 2014
Dear Ms. Greenawalt:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
{1}------------------------------------------------
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K141701
Device Name
Radioactive Seed Localization Needle [RSLN]
Indications for Use (Describe)
The IsoAid RSLN is a device intended for the localization of suscipcious tissues (non-palpable lesions) for excision with the use of radioactive seeds.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/8 description: The image shows the word "ISOAID" in large, green letters. The letters are slightly faded, giving them a textured appearance. Below the word is a curved, orange line that adds a touch of color to the image. The overall design is simple and eye-catching.
K 141701
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: 727-815-1973 | |
|---|---|---|
| Contact Person: | Mary Ann GreenawaltIsoAid Regulatory and Quality | |
| Date of Summary: | 23 JUNE 2014 | |
| Trade Name: | I-125 Radioactive Seed Localization Needle [IA-RSLN] | |
| Common Name: | Source, Brachytherapy, Radionuclide | |
| Classification: | Class II [21 CFR 892.5730, Product Code KXK] | |
| Classification Name: | Radionuclide Brachytherapy Source | |
| Predicate Devices: | Device | 510(k) |
| BrachySciences (Biocompatibles) Radioactive SeedLocalization Needle with Anchor Seed | K111979 | |
| Device Description: | The IsoAid I-125 Radioactive Seed Localization Needle [IA-RSLN] is apre-sterilized 18 gauge needle containing a low-activity I-125 Iodine Seed[K011205]. The needle tip is occluded with bone wax to contain thecontents prior to implant. The iodine seed is loaded loose or stranded and isprovided with or without trailing spacers. The stainless steel needles areprovided in lengths: 5cm, 7cm, and 12cm. The device is used to facilitatethe introduction of the radionuclide seed into the suspicious tissue. Theseed is used singly as a point-source for localization rather than fortherapeutic use as in brachytherapy. The device is packaged and labeled andEtO sterilized. | |
| Intended Use: | The I-125 Radioactive Seed Localization Needle is intended as a temporaryimplant to aid in localization and excision of suspicious tissues It isintended to be used with or without absorbable strands. | |
| Indications for Use: | The I-125 Radioactive Seed Localization Needle is intended for thelocalization of suspicious tissues [non-palpable lesions] for excision withthe use of radioactive seeds. |
IsoAid 510k Summary for I-125 Radioactive Seed Localization Needle
5-1 of 2
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the logo for ISOAID. The text "ISOAID" is written in large, green letters. Below the text is an orange, curved line.
Summary of Technological Characteristics.
The IsoAid I-125 RSLN device has the same intended use and fundamental scientific technology as the predicate device. As with the predicate device, the I-125 RSLN device is an iodine radionuclide seed provided loose or stranded, with or without a trailing spacer. The RSLN device is provided sterile for one-time use only, and meets ISO 2919, ISO 9978, and Type A packaging requirements.
Conclusion.
Based on the above, IsoAid LLC believes the RSLN device is substantially equivalent to the predicate device, and is safe and effective for its intended use.
-end-
IsoAid 510k Summary for I-125 Radioactive Seed Localization Needle
5-2 of 2
§ 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.