(127 days)
Not Found
No
The summary describes a radioactive seed for brachytherapy, a physical device for delivering radiation. There is no mention of software, algorithms, or any technology that would typically incorporate AI/ML.
Yes
The device is described as "intended for the treatment of selected localized tumors" and "implanted as a source of nuclear radiation for therapy," which clearly indicates a therapeutic purpose.
No
The device is described as "a source of nuclear radiation for therapy," indicating its use in treatment, not diagnosis.
No
The device description clearly states it is a physical object (spherical sealed sources of palladium-103 with a titanium capsule) and is implanted, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the treatment of selected localized tumors" and "implanted as a source of nuclear radiation for therapy." This describes a therapeutic device used in vivo (within the body) for treatment, not a diagnostic device used in vitro (outside the body) to examine specimens for diagnostic purposes.
- Device Description: The description details a "spherical sealed source of palladium-103" that is "implanted." This further reinforces its role as a therapeutic implant.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Providing diagnostic information
- Using reagents or assays
Therefore, the IsoAid Palladium Brachytherapy Seeds are a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The IsoAid Palladium Brachytherapy Seeds is intended for the treatment of selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.
Product codes (comma separated list FDA assigned to the subject device)
90 KXK
Device Description
The IsoAid palladium-103 seeds are spherical sealed sources of palladium-103. The outer capsule of the source is sealed titanium. The specifications for the IsoAid device are the same as for the predicate.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
0
APR - 8 2004
Kø33 77ø
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: 727-815-1972 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Max Taghizadeh |
| Date of Summary: | October 31, 2003 |
| Trade Name: | IsoAid Palladium Brachytherapy Seeds |
| Classification: | Class II, Classification number is 90 KXK |
| Classification Name: | Brachytherapy, Radionuclide |
| Predicate Device: | TheraSeed Palladium-103 Model 200 Implant |
| Device Description/Comparison: | The IsoAid palladium-103 seeds are spherical
sealed sources of palladium-103. The outer capsule
of the source is sealed titanium. The specifications
for the IsoAid device are the same as for the
predicate. |
| Intended Use: | The ISOAID Palladium Brachytherapy Seeds is
intended for the treatment of selected localized
tumors. The devices are implanted as a source of
nuclear radiation for therapy. |
1
Image /page/1/Picture/0 description: The image shows a handwritten sequence of characters, "K033779", above the words "Comparison Chart". The characters are written in a cursive style, and the words "Comparison Chart" are underlined. The text is black against a white background.
| | IsoAid Brachytherapy Seeds | TheraSeed Palladium-103
Model 200 |
|------------------------|------------------------------------|--------------------------------------|
| 510(k) Number | To Be Determined | K010283 |
| Indications for Use | Brachytherapy for localized tumors | Same |
| Capsule | Titanium | Same |
| Capsule Sealing Method | Laser Weld | Same |
| Half-Life | 17.0 days | Same |
| Length | 4.5 mm | Same |
| Outside Diameter | 0.8 mm | Same |
| Application Method | Through an 18 gauge needle | Same |
| Apparent Activity | 0.10 to 5.0 mCi | Same |
.
:
:
2
Image /page/2/Picture/1 description: The image shows a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 8 2004
Mr. Max Taghizadeh President IsoAid, LLC 7824 Clark Moody Boulevard PORT RICHEY FL 34668
Re: K033770
Trade/Device Name: IsoAid Advantage Pd-103 Regulation Number: 21 CFR $892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: March 12, 2004 Received: March 15, 2004
Dear Mr. Taghizadeh:
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 CHR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 yours,
Nancy C. Brygdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510 (k) Number (if known): K433270
Device Name:
Advantage™ Pd-103
Indications For Use:
The IsoAid Palladium Brachytherapy Secd is intended for the treatment of selected localized The ISOAN I anathum Brachyalerapy became of nuclear radiation for therapy.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEFLOED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (per 21 CFR 801.109) ાર
()ver the Counter Use
(Optional Format 1-2-96)
Nancy C Broadon
(Division Sign-Off Division of Reproductive, A and Radiological Devices 510(k) Number _