(15 days)
Not Found
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical instruments.
No
Explanation: The device is described as providing instruments for surgical procedures, specifically for dissection and retraction of tissue, and is intended for use by surgeons during operations. It does not state that it treats or
prevents a disease or condition itself.
No
Explanation: The "Intended Use / Indications for Use" states that the device provides instruments for surgical procedures requiring dissection and retraction of tissue, and it utilizes MR visualization. It mentions performing "neurological procedures," which are interventional, not diagnostic in nature. There is no mention of diagnosing conditions or interpreting medical data.
No
The device description explicitly lists physical instruments like retractors, dilators, probes, and a protecting shield, indicating it is a hardware system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that the Flex Arm Retractor System is a surgical instrument used during procedures to manipulate tissue (retract, dilate, probe). It is used in vivo (within the living body) during surgery, not in vitro (outside the body) for testing samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on sample analysis.
- Using reagents or test kits.
This device is a surgical instrument used to facilitate a surgical procedure, not to perform a diagnostic test on a sample.
N/A
Intended Use / Indications for Use
Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room environment.
Product codes
GZT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR visualization
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professional in operating room environment.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4800 Self-retaining retractor for neurosurgery.
(a)
Identification. A self-retaining retractor for neurosurgery is a self-locking device used to hold the edges of a wound open during neurosurgery.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 9 2007
Koros USA, Inc. % CITECH Mr. Robert Mosenkis President 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K071338
Trade/Device Name: Flex Arm Retractor System Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: May 11, 2007 Received: May 14, 2007
Dear Mr. Mosenkis:
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
1
Page 2 - Mr. Robert Mosenkis
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 (240) 276-0115. 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/cdrh/industry/support/index.html.
ncerely vours. ark N. Melkerso Director
Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
MAY - 1 2007
not known 510(k) Number:
Flex Arm Retractor System Device Name:
Indications For Use: Flex Arm Retractor System intended to provide surgeons with instruments such as retractors, dilators, probes, protecting shield to perform a variety of neurological procedures utilizing MR visualization. The device may be used in surgical procedures requiring dissection and retraction of tissue. It is intended to be used by trained medical professional in operating room
environment.
AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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011-Division of General, Restorative, and Neurological Devices