(29 days)
ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
ONC Markers exist as a series of individual gold ring members connected over a gold inner wire. The ring members can be of different diameters and different quantities can be joined together to form longer length markers. The markers will range in nominal diameter from 0.35mm to 1.2mm. The markers will range in overall length from 10mm to 60mm. ONC Markers are packaged in two different formats: A. Markers inside sterile packages for single use only B. Markers inside Preplugged Introducer Needles, inside sterile packages for single use only Sterilization is achieved by a validated EO sterilization method.
This 510(k) submission for the ONC Marker is for a physical medical device (a tissue marker) and does not include information about an AI/ML-based device or a study involving AI performance.
Therefore, most of the requested information (acceptance criteria for AI, training/test set details, expert ground truth, MRMC study, standalone performance, etc.) is not applicable and cannot be extracted from the provided text.
The document primarily focuses on establishing substantial equivalence to predicate devices based on material, size range, and intended use, rather than on performance metrics from a clinical study as would be expected for an AI device.
Here's what can be extracted based on the provided text, recognizing the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a physical device and not an AI algorithm, the concept of "acceptance criteria" for performance is typically tied to manufacturing specifications and safety standards rather than diagnostic accuracy metrics. The document mentions compliance with general medical device regulations.
| Acceptance Criteria / Performance Aspect | Reported Device Performance (from submission) |
|---|---|
| Material | Pure metallic gold (identical to predicate devices) |
| Diameter Range | 0.35mm to 1.2mm (identical to predicate devices) |
| Overall Length Range | 10mm to 60mm (identical to predicate devices) |
| Intended Use | To radiographically mark soft tissue for future therapeutic procedures (identical to predicate devices) |
| Manufacturing Standards | Manufactured, labeled, and packaged in accordance with current FDA QSR (21 CFR Part 820) |
| Sterilization | Achieved by a validated EO sterilization method |
| Delivery Method | Delivered through preloaded introducer needles or loaded into similar needles at implantation site |
| Fundamental Scientific Technology | Has not changed compared to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This document describes a physical medical device, not an AI/ML system that would typically undergo testing with a "test set" of data. Performance is established through comparison to predicate devices and adherence to manufacturing and sterilization standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. No ground truth establishment by experts for a test set is mentioned as this is not an AI/ML device.
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:
- No. This is a physical marker and not an AI system. Such a study would not be relevant.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm.
7. The Type of Ground Truth Used:
- Not applicable. For a physical device like this, "ground truth" typically refers to engineering verification and validation (e.g., material composition, dimensions meeting specifications, sterility achieved), not a clinical 'truth' established for diagnostic accuracy. The substantial equivalence argument is based on comparison to legally marketed predicate devices, not on a new clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable. There is no AI/ML model, hence no training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable. There is no AI/ML model, hence no training set ground truth.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (tissue marker) and lacks the specific details requested for an AI/ML-based device performance study.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "ONC" in bold, sans-serif font. Above the letters "ONC" is a stylized graphic that resembles a person with a circular head. Below the letters "ONC" is the word "SOLUTIONS" in a smaller, sans-serif font. The logo is black and white.
Image /page/0/Picture/1 description: The image shows a handwritten document with the code "K071673" at the top. Below the code, there is a signature or name written in cursive, which is difficult to read due to the handwriting style. The writing appears to be done with a dark ink or marker on a white background.
JUL 1 8 2007
510(k) Summary
- Sponsor Name Address
Contact Phone Contact Fax
ONC Solutions, Inc. 84 Sugar Hill Lane Manchester, NH 03109 (603) 566-5001 (603) 206-5131
Contact Individual Prepared On
John Schwamb June 13, 2007
-
- Device Name
| Proprietary Name: | DNC Marker |
|---|---|
| Common/Usual Name: | ONC Marker |
| Classification Name: | Accelerator, Linear, Medical |
-
- Device Description
ONC Markers exist as a series of individual gold ring members connected over a gold inner wire. The ring members can be of different diameters and different quantities can be joined together to form longer length markers. The markers will range in nominal diameter from 0.35mm to 1.2mm. The markers will range in overall length from 10mm to 60mm.
- Device Description
ONC Markers are packaged in two different formats:
- A. Markers inside sterile packages for single use only
- B. Markers inside Preplugged Introducer Needles, inside sterile packages for single use only
Sterilization is achieved by a validated EO sterilization method.
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K-7:672
Sugi Zapp
Image /page/1/Picture/1 description: The image shows a logo with the letters "ONC" in bold, sans-serif font. Below "ONC" is the word "SOLUTIONS" in a smaller, sans-serif font. To the left of the text is a stylized graphic that resembles a person inside of a circle. The graphic is black and white.
ONC Markers will be manufactured, labeled, and packaged in accordance with the current FDA QSR. To ensure compliance to specifications, upon completion of the manufacturing process the device will be inspected and tested in accordance with ONC Solutions' standard operating procedures.
ONC Markers are typically delivered through one of the preloaded introducer needles supplied by ONC Solutions. ONC Markers may also be loaded into similar needles at the implantation site.
-
- Intended Use
The intended use for this new device is identical to that of its two predicate devices.
- Intended Use
The ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
-
- Comparison of Technological Characteristics
The fundamental scientific technology of the modified device has not changed.
- Comparison of Technological Characteristics
Predicate Devices:
K031206 RadioMed Soft Tissue Marker K070305 Preloaded RadioMed Soft Tissue Marker
- . The material used for both of the predicate devices and the ONC Marker is pure metallic gold.
- . The diameter range for both of the predicate devices and the ONC Marker are 0.35mm to 1.2mm.
- The overall length range for both of the predicate devices and the ONC Marker is . 10mm to 60mm.
- The intended use for both of the predicate devices and the ONC Marker is . identical.
The change to this product includes the following:
- Predicate devices exist in the form of a coil while the modified device is in the . form of multiple ring members joined over an inner wire.
-
- Performance Testing
Summary of Standards Achieved: FDA QSR 21 CFR Part 820 Current Good Manufacturing Practices
ONC Solutions Inc. . 84 Sugar Hill Lane Manchester NH 03109 . Tel: (603) 566-5001 . Fax: (603) 206-5131 http://www.oncsol.com
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Mr. John Schwamb President ONC Solutions, Inc. 84 Sugar Hill Lane MANCHESTER NH 03109
Re: K071673
Trade/Device Name: ONC Marker Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: June 13, 2007 Received: June 19, 2007
Dear Mr. Schwamb: :
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/2/Picture/9 description: The image is a black and white circular seal. The seal contains the letters "FDA" in a stylized font. Above the letters, the numbers "1906-2006" are printed. Below the letters, the word "Centennial" is printed, along with three stars. The text "Department of Health" is printed along the bottom of the seal.
Protecting and Preserving Public Health
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Page 2 -
Enclosure
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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C Hodgon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known):
Device Name:
ONC Marker
Indications for Use:
ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hut Remur
TtDivision Sign Division of Reproductive, Abdominal, & and Radiological Devices
510(k) Number
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.