(164 days)
Not Found
No
The device description focuses on a physical needle and radioactive seed for localization, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
No.
The device description clearly states, "The seed is used singly as a point-source for localization rather than for therapeutic use as in brachytherapy."
No
The device is used for the localization of suspicious tissues for excision, meaning it helps to identify the location of existing lesions so they can be removed. It does not diagnose the presence or nature of the disease itself.
No
The device description clearly states it is a pre-sterilized 18 gauge needle containing a radioactive seed, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The IsoAid RSLN is a device used to implant a radioactive seed into the body for the purpose of localizing tissue for surgical excision. It is an invasive procedure performed in vivo (within the living body).
- Intended Use: The intended use clearly states "for the localization of suspicious tissues (non-palpable lesions) for excision". This is a surgical/interventional procedure, not a diagnostic test performed on a sample.
Therefore, the IsoAid RSLN falls under the category of a medical device used for a surgical/interventional procedure, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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 I-125 Radioactive Seed Localization Needle is intended as a temporary implant to aid in localization and excision of suspicious tissues It is intended to be used with or without absorbable strands.
The I-125 Radioactive Seed Localization Needle is intended for the localization of suspicious tissues [non-palpable lesions] for excision with the use of radioactive seeds.
Product codes (comma separated list FDA assigned to the subject device)
KXK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
suspicious tissues (non-palpable lesions)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
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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
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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)
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K 141701
510 (k) SUMMARY (As required by 807.92(c))
| Submitter of 510(k): | IsoAid, LLC
7824 Clark Moody Blvd., Port Richey, FL 34668
Phone: 727-815-3262
Fax: 727-815-1973 | |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person: | Mary Ann Greenawalt
IsoAid 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 Seed
Localization Needle with Anchor Seed | K111979 |
| Device Description: | 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. | |
| Intended Use: | The I-125 Radioactive Seed Localization Needle is intended as a temporary
implant to aid in localization and excision of suspicious tissues It is
intended to be used with or without absorbable strands. | |
| Indications for Use: | The I-125 Radioactive Seed Localization Needle is intended for the
localization of suspicious tissues [non-palpable lesions] for excision with
the use of radioactive seeds. | |
IsoAid 510k Summary for I-125 Radioactive Seed Localization Needle
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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
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