(24 days)
The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of select localized tumors with low to moderate radiosensitivity. They are used either as a primary treatment for tumors such as those of the head, lung, neck, pancreas, prostate, or as a boost to the primary tumor.
The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the completion of external beam radiation therapy or chemotherapy.
The provided text is a Premarket Notification (Special 510(k) Device Modification) for the "EZ-Pak" device, which is a packaging change to existing brachytherapy sources. This document does not contain information about acceptance criteria or a study proving the device meets those criteria, as it pertains to a packaging modification rather than a new functional device requiring performance validation.
Therefore, I cannot extract the requested information based on the provided text. The document focuses on establishing substantial equivalence for the packaging modification and maintains the intended use of the previously cleared brachytherapy sources.
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JUL 1 6 2004
| IBt | 21 June 2004 | CONFIDENTIAL Page 16 of 16 |
|---|---|---|
| Title: | Premarket Notification: Special 510(k) Device Modification - EZ-Pak™ | |
| 510(k) Summary | ||
| Applicant /Manufacturing Site: | ||
| IBt s.a. | ||
| Zone Industrielle C7180 Seneffe – Belgium | ||
| Tel: | (+32) 64 / 520 811 | |
| Fax: | (+32) 64 / 520 801 | |
| Establishment Registration Number: | 9031509 (IBt s.a.) | |
| Contact Person IBt s.a.: | Sylviane Berger, Management Representative | |
| E-mail: | sberger@brachytherapy.be | |
| Official Correspondent: | ||
| IBt Inc. | ||
| 6000 Live Oak Parkway, Suite 107 | ||
| Norcross, GA 30093 | ||
| Tel: | (770) 582 0662 | |
| Fax: | (770) 582 0657 | |
| Establishment Registration Number: | 9035105 (IBt, Inc.) | |
| Contact Person IBt, Inc .: | Ruth Feicht, President | |
| E-mail: | rfeicht@ibt4seeds.com | |
| Device Information | ||
| Trade Name: | EZ-Pak (EZ-Pak™ is a Trademark of IBt s.a.) | |
| Model Number: | Not Applicable | |
| Common Name of Device | Preloaded needles / cartridges, sealed source; seed; interstitial implant | |
| Type of 510(k) Submission: | Special 510(k) Device Modification | |
| Classification Information | ||
| Classification: | Radionuclide Brachytherapy Source Class II device | |
| Class of Device: | 21 CFR 892.5730, Class II | |
| Product Code: | 90-KXK | |
| Intended Use | ||
| EZ-Pak™ is a packaging change to InterSource 103 (#K973328), InterSource 125 | ||
| (#K9984235) and InterStrand ® (#K011155). There is no change in the intended | ||
| use of these cleared sources. Please see the referenced Premarket Notification | ||
| documents for Statements of Intended Use. |
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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 features a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2004
Ms. Ruth Feicht President International Brachytherapy, Inc. 6000 Live Oak Parkway, Suite 107 NORCROSS GA 30093
Re: K041702
Trade/Device Name: EZ-Pak Preload Needles Regulation Number: 21 CFR 892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: 90 KXK Dated: June 21, 2004 Received: June 23, 2004
Dear Ms. Feicht:
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 such 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 (OS) 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 yours,
Nancy C. Brundin
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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Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ K041702
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The sources in EZ-Pak Preloaded Needles are indicated for interstitial implantation of The sources in EZ-PaK Preloaded Neconce are insteasitivity. They are used either as a select localized tumors with to moderate fablessial, lung, neck, pancreas, prostate,
primary treatment for tumors such as those of the head, lung, neck, parces turner primary treatment for tumors such as thous of the nead, it of the primary tumor.
The source in EZ-Pak Preloaded Needles are indicated for use concurrent with or at the The source in EZ-PaK Freioaded Necolles are intributes are madiation therapy or chemotherapy.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
e-Counter Use
FR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive. Abdomin and Radiological Devices 510(k) Number _
§ 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.