(64 days)
The applicators will be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.
The applicator sets in this submission are designed to be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors. The Intracavitary applicators are designed to be inserted into a body cavity. Six intracavitary applicator sets are included in this submission.
The provided text is a 510(k) Summary for Intracavitary Brachytherapy Applicators. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a clinical study with detailed statistical outcomes.
Therefore, many of the requested details about acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment are not typically included or required in a 510(k) Summary for a device like this. The focus is on comparing the new device to an existing one regarding intended use and technological characteristics.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of this 510(k) submission. A 510(k) for a device like these brachytherapy applicators does not typically establish performance acceptance criteria with numerical targets. Instead, the "performance" criteria are met by demonstrating substantial equivalence to a predicate device in terms of intended use, technological characteristics (materials), and safety. The letter from the FDA confirms that the device was found substantially equivalent.
| Acceptance Criteria (Inferred from 510(k) Process) | Reported Device Performance (from text) |
|---|---|
| Substantial Equivalence to Predicate Device (K983436) in materials. | "The applicators are identical or equivalent to the predicate devices in materials." |
| Substantial Equivalence to Predicate Device in intended use (gynecological and rectal brachytherapy for cancerous tumors). | The intended uses described for each applicator (e.g., "treatment of cancerous gynological tumors", "treat cancer of the vagina or rectum") align with typical brachytherapy applications, implicitly similar to the predicate. |
2. Sample size used for the test set and the data provenance
Not applicable. This 510(k) summary does not describe a clinical performance study with a test set of data. The "test" for a 510(k) is the comparison of the device's characteristics to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No test set requiring expert ground truth establishment is described in this 510(k) summary.
4. Adjudication method for the test set
Not applicable. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a passive medical device (brachytherapy applicators), not an AI-powered diagnostic or interpretive system. No MRMC study was conducted or is relevant for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. There is no performance study where "ground truth" for a dataset would be established. The "truth" in a 510(k) is the demonstration that the new device is as safe and effective as the predicate device, primarily through comparison of design, materials, and intended use.
8. The sample size for the training set
Not applicable. This 510(k) summary does not describe an AI/ML algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, no ground truth for it would be established.
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DEC 2 4 2003
V
me
Varian Medical Systems, Inc. 3100 Hansen Way Palo Alto, CA 94304-1038 USA tel +1 650 493 4000 www.varian.com
510(k) Summary
The following information is provided following the format of 21 CFR 807.92 for the Intracavitary Brachytherapy Applicators
| 1) Submitter: | Varian Medical Systems, Inc.3100 Hansen Way/ MS E-110Palo Alto, California 94304 |
|---|---|
| Contact Person: | Vy Tran, Director, Corporate Regulatory Affairs |
| Telephone: | (650) 424 5731 |
| Facsimile: | (650) 842 5040 |
| Email: | vy.tran@varian.com |
| Date Prepared: | October 16, 2003 |
- Intracavitary BrachyTherapy Applicators Device Name: 2) 11-00404 Cervix Applicator Set; 11-00414 Vaginal Applicator Set; 11-00415 Segmented Cylinder Set; 11-00416 Stump Applicator Set; 11-00438 Shielded Applicator Set; 11-00454 Segmented Cervix Applicator Set
- Intracavitary Brachytherapy Applicators Common Name:
Predicate Device 3) GammaMed Plus High Dose Rate Afterloader System Name: applicators, K 983436
- The applicator sets in this submission are designed to be used Description: 4) with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors. The Intracavitary applicators are designed to be inserted into a body cavity.
- Six intracavitary applicator sets are included in this submission. Intended Use: 5) The intended use of each applicator is described below.
11-00404 Cervix Applicator Set
Cervix Applicator set is designed for use in medical intracavitary brachytherapy for treatment of cancerous gynological tumors. It is suitable (combined) irradiation of the vagina and the endometrium. It is also to irradiate the uterus, vaginal stump or rectum. The maximum implantation time for this applicator is 2 days.
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K 633371
p2 of 2
11-00414 Vaginal Applicator Set
Vaginal Applicator Set is developed for intracavitary brachytherapy to treat cancer of the vagina or rectum. The maximum implantation time for this applicator is 30 days.
11-00415 Segmented Cylinder Set
Segmented Cylinder Set is developed to treat cancer of the vagina and the vaginal stump. It is also suitable to treat rectal cancer. The applicator set is MR and CT compatible. The maximum implantation time for this applicator is 2 days.
11-00416 Stump Applicator Set
Stump Applicator Set is developed for post-operative irradiation of the vaginal stump. The flexible applicator probe has a connector made of titanium, so that position checks can be made using CT or MRI. The maximum implantation time for this applicator is 30 days.
11-00438 Shielded Applicator Set
Shielded Applicator Set is developed to treat cancer of the vagina or rectum where partial shielding is required. The maximum implantation time for this applicator is 2 days.
11-00454 Segmented Cervix Applicator Set
Segmented Cervix Applicator Set is developed to irradiate the cervix, the vagina and the vaginal stump. The applicator set is MR and CT compatible. The cylinder segments can be used with cervical sleeves (Smit), flexible intra-uterine probes or without intra-uterine probes. The segmented construction of the applicator allows an individual adaptation to the patient's anatomy. The maximum implantation time for the Segmented Cervix Applicator is 7 days.
Technological 6) Considerations:
The applicators are identical or equivalent to the predicate devices in materials.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 4 2003
Ms. Vy Tran Director, Corporate Regulatory Affairs VARIAN Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038
Re: K033371
Trade/Device Name: Intracavitary Brachy Therapy Applicators Regulation Number: 21 CFR 892.5700 Regulation Name: Remote controlled radionuclide applicator system Regulatory Class: II Product Code: 90 JAQ Dated: October 16, 2003 Received: October 21, 2003
Dear Ms. Tran:
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 (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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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. Brogdon
Nancy C. Brogdor Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):
- Device Name: Intracavitary BrachyTherapy Applicators 11-00404 Cervix Applicator Set; 11-00414 Vaginal Applicator Set; 11-00415 Segmented Cylinder Set: 11-00416 Stump Applicator Set; 11-00438 Shielded Applicator Set; 11-00454 Segmented Cervix Applicator Set)
Indications for use:
The applicators will be used with the VariSource High Dose Rate Afterloaders to deliver brachytherapy treatment for gynecological and rectal applications. The applicators will be used in medical intracavitary for treatment of cancerous tumors.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
David h. Aezom
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.