(35 days)
Not Found
No
The 510(k) summary describes a radioactive source for brachytherapy and does not mention any AI or ML components in its description, intended use, or performance studies.
Yes
The indicated use of the device is for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors, which is a therapeutic purpose.
No
The device is described as a brachytherapy source used for treating localized tumors, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical brachytherapy source consisting of a stainless steel capsule containing radioactive pellets attached to a cable. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for treating localized tumors through radiation therapy (brachytherapy). This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a radioactive source designed to be implanted or applied to the body for treatment.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Implant Sciences Model HDR 4454 Source Assembly is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use of Implant Sciences Corp. Model HDR 4454 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation.
Implant Sciences Model HDR 4454 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.
This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.
Product codes (comma separated list FDA assigned to the subject device)
KXK
Device Description
Implant Sciences Corp. Model HDR-4454 is a singly-encapsulated 160 Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive feer thium pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast
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
Image /page/0/Picture/0 description: The image shows the logo for Implant Sciences Corporation. The logo consists of a stylized graphic to the left of the company name. The graphic is a black geometric shape with several vertical lines running through it. The company name is written in a bold, sans-serif font, with "IMPLANT SCIENCES" on the top line and "CORPORATION" on the bottom line.
MAR 2 3 2007
Section 5 510(k) Summ
Section 807.92(a)
Submitter (1) Implant Sciences Corp. 781.246.0700 Tel: 107 Audubon Road #5 Fax: 781.246.1167 Wakefield, MA 01880
Establishment Registration No .: 1226547
Contact Person: Matthew Hollows Director, Brachytherapy Products e-mail: mhollows@implantsciences.com
- (2) Device Name:
Classification Name: Radionuclide Brachytherapy Source (892.5730) (90 KXK)
Common or Usual Name: Brachytherapy Source Assembly
Proprietarv Name: Implant Sciences Corp. Model HDR-4454
- (3) Legally Marketed Predicate Devices: Implant Sciences Corp. Model HDR-4140, cleared under 510(k) number K042864 dated 06 January 2005
- Description of Implant Sciences Corp. Model HDR-4454 1688 tterbium Brachytherapy Source: (4)
Implant Sciences Corp. Model HDR-4454 is a singly-encapsulated 160 Ytterbium Brachytherapy Source. It consists of a stainless steel capsule containing solid radioactive feer thium pellets. The pellets are sealed in a stainless steel capsule that is attached to a cable to permit manipulation by the remote afterloading system.
-
(5) Intended Use
The intended use of Implant Sciences Corp. Model HDR 4454 Brachytherapy Source is for the treatment of cancer by temporary interstitial, intracavitary, intraluminal, intraoperative or surface irradiation. -
(6) Technological Characteristics:
Implant Sciences Corp. Model HDR-4454 188Ytterbium Brachytherapy Source is similar to the predicate high dose rate brachytherapy source, Model HDR-4140 (K042864) that utilizes photons from 169 Ytterbium.
1
Image /page/1/Picture/1 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Blvd., Rockville MD 20850. The text is in a simple, sans-serif font and is left-aligned.
Mr. Matthew Hollows Director of Brachytherapy Products Implant Sciences Corporation 107 Audobon Road #5 WAKEFIELD MA 01880
MAR 23 2007
Re: K070468
Trade/Device Name: Implant Sciences Corp. Model HDR-4454 169 Ytterbium Brachytherapy Source
Regulation Number: 21 CFR §892.5730 Regulation Name: Radionuclide brachytherapy source Regulatory Class: II Product Code: KXK Dated: February 9, 2007 Received: February 21, 2007
Dear Mr. Hollows:
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 (Premarket Approval), 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.
Image /page/1/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, followed by the letters "FDA" in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are arranged in a horizontal line below the word "Centennial". The text "U.S. Food & Drug Administration" is arranged around the circle.
Protecting and Promoting Public Health
2
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 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 this letter:
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number:
Device Name: Implant Sciences Corp. Model HDR-4454 168Ytterbium Brachytherapy Source
Indications for Use:
Implant Sciences Model HDR 4454 Source Assembly, with individual activity up to 27Ci, is indicated for temporary interstitial, intracavitary, intraluminal or intraoperative or surface application to treat selected localized tumors. This source can be used as primary treatment for a variety of anatomical sites commonly treated with high dose rate brachytherapy, including the cervix, vagina, endometrium, rectum, esophagus, bronchus, head and neck, bile duct brain, skin, prostate, lung, pancreas, and breast and for treatment of sarcomas and for intraoperative radiation therapy.
This source may be used concurrently with or following treatment with other interventions, such as external beam radiation therapy, hyperthermia or chemotherapy.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use -----
David h. Slayton
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K070468