(34 days)
Not Found
No
The description focuses on mechanical retraction and access, with no mention of AI/ML terms or functionalities.
No
The device is a retractor, providing surgical access and holding tissue, not directly treating a disease or condition.
No
Explanation: The device is described as a surgical retractor, intended to provide access to the spine for surgical instruments. It does not mention any function related to diagnosing medical conditions.
No
The device description explicitly lists physical components (frame, arm, blades, tubes) and describes their function in providing surgical access, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is intended to provide minimally invasive surgical access to the spine. This is a surgical tool used during a procedure on a patient.
- Device Description: The description details a physical retractor system (frame, arm, blades, tubes) used to hold tissue open during surgery.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical instrument used to facilitate a surgical procedure.
N/A
Intended Use / Indications for Use
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated.
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, microscopes and surgical instruments can be manipulated.
Product codes (comma separated list FDA assigned to the subject device)
GZT
Device Description
Instrumed Retractors (frame, arm, blades, tubes) provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement and positioning of the retractor posterior, anterior cervical and down to the laminalspine, with its attachment to a rigid frame or a flexible arm to provide a self locking method of access to the spinal site through which a endoscope and/or surgical instruments can be manipulated.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine, laminalspine, lamina
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)
The presented data that was conducted on the Instrumed Retractors shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market (international) for many years with no device failures. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.
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.
K050706, K992898, K935529, K964402
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
§ 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).
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»Summary of Safety & Effectiveness
510(k) Summary as required by section 807.92(c)
date prepared 5/30/2007
Submission Applicant:
INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Establishment Registration Number:
1421101
Official Correspondent:
Mr. Berndt Fetzer INSTRUMED INTERNATIONAL, INC. 626 Cooper Court Schaumburg, IL 60173
Phone: 847-908-0292
Trade name: Instrumed Retractors
Common name: Retractor
Classification name: Retractor (21 CFR 882.4800, Product code GZT)
Substantial Equivalence Claim:
K050706; Harmony Port System, Spinal Concepts, Inc.
K992898; Bright Medical Dilation Retractor System, Bright Medica! Instruments
K935529; Cervical Self-Retaining Retractor, T. Koros Surgical Instruments Corp.
K964402; Versatrac ™ Lumbar Retractor System, V. MUELLER CARDINAL HEALTH
Description of the Device:
Instrumed Retractors (frame, arm, blades, tubes) provide the surgeon with minimally invasive surgical access to the spine by ensuring the placement and positioning of the retractor posterior, anterior cervical and down to the laminalspine, with its attachment to a rigid frame or a flexible arm to provide a self locking method of access to the spinal site through which a endoscope and/or surgical instruments can be manipulated.
AUG - 2 2007
1
»Summary of Safety & Effectiveness
Indications for Use:
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, endoscopes and surgical instruments can be manipulated.
Comparison with P.D.
The Instrumed product is similiar to the P.D. in terms of technical characteristics, design, Indications for Use, Target population, where it is used, performance, biocompatibility, sterilisation method, mechanical safety characteristics as well as sizes and configurations. Therefore it can be deemed substantially equivalent and safe and effective for its indicated use.
Summary
The presented data that was conducted on the Instrumed Retractors shows in its results and in comparison to the predicate devices that the products are absolutely safe and effective for their intended use and do not raise any new questions regarding safety and effectiveness. All models that are covered by this 510(k) premarket notification have been on the market (international) for many years with no device failures. The used materials are well researched and do not raise new questions regarding safety and effectiveness of the finished product.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the circumference. Inside the circle is a stylized graphic of three human profiles facing to the right, resembling a bird in flight.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Instrumed International, Inc. % Mr. Michael Massong RA/OA Director 626 Cooper Court Schaumburg, Illinois 60173
AUG - 2 2007
Re: K071771
Trade/Device Name: Instrumed Retractors Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: II Product Code: GZT Dated: May 30, 2007 Received: June 29, 2007
Dear Mr. Massong:
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
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Page 2 - Mr. Michael Massong
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.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Sincerely yours.
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Instrumed RETRACTORS
Indications For Use:
INSTRUMED retractors are devices intended to provide minimally invasive access to the spine by ensuring the placement, positioning of the retractor down to the lamina, with its attachment to a flexible arm to provide a self locking method of access to the spinal site through which tubes, microscopes and surgical instruments can be manipulated.
| Prescription Use (Part 21 CFR 801 Subpart D) | X | AND/OR | Over-The-Counter Use (21 CFR 801 Subpart C) | |
|---|---|---|---|---|
| ---------------------------------------------- | --- | -------- | --------------------------------------------- | -- |
(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)
(Division Sign-Off)
Concurrence of CDRH, Division of General, Restorative, Division of Evaluation (ODE) and Neurological Devices
| 510(k) Number | k07177 |
|---|---|
| --------------- | -------- |
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