(34 days)
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 (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.
The provided document, K071771, is a 510(k) Pre-Market Notification Summary for the Instrumed Retractors. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical studies with acceptance criteria for device performance as would be expected for novel devices or higher-risk classifications.
Therefore, much of the requested information regarding detailed acceptance criteria, specific device performance metrics, sample sizes for test/training sets, expert adjudication methods, and ground truth establishment is not present in this document because it is not typically required nor performed for a 510(k) submission of this nature.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no quantitative table of acceptance criteria or specific device performance reported in a measurable way (e.g., accuracy, sensitivity, specificity, mechanical durability numbers). The 510(k) submission for the Instrumed Retractors relies on demonstrating "substantial equivalence" to predicate devices, meaning it performs similarly and is as safe and effective.
The summary states:
"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."
This is a general statement of equivalency rather than specific, quantified performance against predefined acceptance criteria. Testing likely involved mechanical testing to ensure the device performs its intended function (e.g., maintaining position, retracting tissue) and material safety, but specific performance metrics are not listed.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable/Not provided. The document does not describe a clinical "test set" in the context of a prospective study to evaluate new performance metrics. The claim is based on comparison to predicate devices and the fact that "All models that are covered by this 510(k) premarket notification have been on the market (international) for many years with no device failures." This implies real-world usage data, but a formal "test set" with a defined sample size as for a new performance study is not discussed.
- Data Provenance: The statement "have been on the market (international) for many years with no device failures" suggests the data provenance is historical, real-world usage from established markets, likely outside the US initially, given the international mention. This is retrospective observational data rather than a controlled prospective study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment by experts for a specific test set is described, as the submission relies on substantial equivalence and historical performance rather than a new clinical performance study requiring such an assessment.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This type of study is not mentioned or implied. The device is a surgical retractor, not an imaging or diagnostic device that would typically involve a multi-reader study. The comparison is between the new device and predicate devices based on design, materials, and intended use, not human reader performance with or without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was done:
Not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used:
Not applicable in the conventional sense of establishing a medical diagnosis. The "ground truth" here is implied to be the proven safety and effectiveness of the predicate devices over time, coupled with the assertion that the new device shares similar characteristics and has also performed reliably ("no device failures") in prior (international) market use. The safety of the materials is also a "ground truth" established through prior research and use.
8. The Sample Size for the Training Set:
Not applicable. There is no mention of a training set, as this is not an AI/algorithm-driven device.
9. How the Ground Truth for the Training Set was Established:
Not applicable. There is no training set for this type of device submission.
In summary, for K071771, the "study" that proves the device meets (implied) acceptance criteria is a demonstration of substantial equivalence to predicate devices and the historical safety record of the Instrumed Retractors in international markets. This is a common pathway for Class II medical devices that are similar to existing ones, and it does not involve the detailed clinical trial and performance metric reporting often associated with novel medical technologies or higher-risk devices.
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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
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»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.
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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
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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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§ 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).