(29 days)
Not Found
No
The device description and intended use describe a physical marker for radiographic procedures, with no mention of software, algorithms, or any AI/ML related terms.
No
The device is described as a marker for radiological identification for future therapeutic procedures, not as a therapeutic device itself.
No
The device is described as a marker used to radiographically mark soft tissue for future therapeutic procedures, which is a structural or passive function, not a diagnostic one. It doesn't capture, analyze, or interpret data to identify a disease or condition.
No
The device description clearly describes a physical medical device made of gold rings and wire, packaged in sterile containers or preplugged needles. It does not mention any software component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiographically mark soft tissue for future therapeutic procedures." This describes a physical marker placed within the body for imaging purposes, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The description details a physical implant made of gold rings and wire. This is a medical device, not a reagent, instrument, or system used for in vitro testing.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
This device is clearly a radiopaque marker, which is a type of medical device used for imaging guidance or marking anatomical locations.
N/A
Intended Use / Indications for Use
The ONC Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.
Product codes (comma separated list FDA assigned to the subject device)
IYE
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.
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Summary of Standards Achieved: FDA QSR 21 CFR Part 820 Current Good Manufacturing Practices
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.
K031206 RadioMed Soft Tissue Marker, K070305 Preloaded RadioMed Soft Tissue Marker
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
§ 892.5050 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.
0
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.
1
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
2
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
3
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
4
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