ISOAID ADVANTAGE PD-103, MODEL IAPD-103A

K033770 · Isoaid, LLC · KXK · Apr 8, 2004 · Radiology

Device Facts

• Record ID: K033770
• Device Name: ISOAID ADVANTAGE PD-103, MODEL IAPD-103A
• Applicant: Isoaid, LLC
• Product Code: KXK · Radiology
• Decision Date: Apr 8, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5730
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

IsoAid Palladium Brachytherapy Seeds are spherical, sealed radionuclide sources containing Palladium-103. Designed for implantation into localized tumors to provide targeted radiation therapy. The device is delivered via an 18-gauge needle. Operation is performed by a physician. The seeds function as a permanent implant, emitting radiation to treat the tumor site. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological and physical comparison to the predicate device.

Technological Characteristics

Radionuclide brachytherapy source. Materials: Titanium capsule. Sealing: Laser weld. Dimensions: 4.5 mm length, 0.8 mm diameter. Energy source: Palladium-103 (17.0-day half-life). Apparent activity: 0.10 to 5.0 mCi. Delivery: 18-gauge needle.

Indications for Use

Indicated for the treatment of selected localized tumors in patients requiring brachytherapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• TheraSeed Palladium-103 Model 200 Implant (K010283)

Submission Summary (Full Text)

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

APR - 8 2004

Kø33 77ø
510(k) SUMMARY

## (as required by 807.92(c))

| Submitter of 510(k): | IsoAid, LLC<br>7824 Clark Moody Blvd.<br>Port Richey, FL 34668<br>Phone: [phone]<br>Fax: [phone] |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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<br>sealed sources of palladium-103. The outer capsule<br>of the source is sealed titanium. The specifications<br>for the IsoAid device are the same as for the<br>predicate. |
| Intended Use: | The ISOAID Palladium Brachytherapy Seeds is<br>intended for the treatment of selected localized<br>tumors. The devices are implanted as a source of<br>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<br>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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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 _