(42 days)
The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during all supratentorial and infratentorial skull operations.
The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are surqical accessories that affix to the appropriately sized surgical bars surrounding the patient's head during neurosurgical procedures. The clamps interact with elastic scalp retraction hooks to assist with the self-retaining retraction of the scalp during neurosurgical procedures. The clamps are offered in two versions (Snap-On and Slide-On) and each version is offered in two sizes (0.5" and 20mm) to accommodate most commonly used surgical accessory bars.
This document describes the Spetzler Snap-On/Slide-On Scalp Retractor Clamps and their intended use. The information provided is primarily for regulatory submission (510(k) summary) rather than a detailed study report. Therefore, much of the requested information regarding acceptance criteria and a specific study proving device performance in a clinical or statistical sense (e.g., sample sizes, expert ground truth, MRMC studies) is not present. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.
Here's an attempt to answer the questions based only on the provided text, highlighting what is available and what is not:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a numerical table format for characteristics like strength, durability, or exact fit. Instead, it refers to a qualitative assessment of "functional characteristics."
| Characteristic / Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional characteristics equivalent to predicate devices | "Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics." |
| Affix to appropriately sized surgical bars | The clamps "affix to the appropriately sized surgical bars." |
| Interact with elastic scalp retraction hooks | The clamps "interact with elastic scalp retraction hooks." |
| Accommodate commonly used surgical accessory bars (0.5" and 20mm) | Offered in "two versions (Snap-On and Slide-On) and each version is offered in two sizes (0.5" and 20mm) to accommodate most commonly used surgical accessory bars." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document globally refers to "non-clinical tests" without detailing the number of units tested, the number of surgical bars it was tested with, or the number of different hooks used.
- Data Provenance: Not specified. It's implied the testing was conducted by Cardinal Health, likely in the US (their address is in Illinois, USA). The document does not specify if the testing involved human subjects or patient data. Given the nature of a scalp retractor clamp, "non-clinical tests" would typically refer to bench or mechanical testing.
- Retrospective or Prospective: N/A, as this refers to non-clinical bench testing, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document only mentions "Performance testing demonstrated..." without detailing who conducted or evaluated this performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No, an MRMC study was not done. This device is a mechanical surgical accessory, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, this question is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a mechanical device, not an algorithm. The "standalone" performance would be its functional performance as described in the non-clinical tests.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this mechanical device, "ground truth" would refer to its designed specifications and functional requirements.
- Type of Ground Truth: The "non-clinical tests" assessed "design performance and conformance to design specifications." This implies the ground truth was the device's design specifications and functional requirements itself, as evaluated through engineering and mechanical testing. The comparison point ("substantially equivalent") was against predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set.
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MAR 1 8 2009
Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic is composed of three curved lines that converge at one end, resembling a bird in flight or a stylized leaf.
1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6442 FAX: 847.785.2506
SMDA REQUIREMENTS
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS As required by section 807.92(c) Spetzler Snap-On/Slide-On Scalp Retractor Clamps
| Sponsor: | Cardinal Health1430 Waukegan Road MPKBMcGaw Park, IL 60085 |
|---|---|
| Regulatory Affairs Contact: | Gina Rajterowski |
| Telephone: | (847) 578-6442 |
| Fax: | (847) 785-2506 |
| Date Summary Prepared: | January 2009 |
| Device Name | Spetzler Snap-On/Slide-On Scalp RetractorClamps |
| Common Name | Clamp accessory used for self-retainingretraction |
| Classification Name | Self-retaining retractor for neurosurgery (21CFR, 882.4800, Product Code GZT) |
| Predicate Device(s) | Rhoton-Merz Self-Retaining Brain RetractorSystem, K895395Leyla Self-Retaining Brain Retractor SystemPreamendment device |
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| Description: | The Spetzler Snap-On/Slide-On Scalp RetractorClamps are surqical accessories that affix to theappropriately sized surgical bars surroundingthe patient's head during neurosurgicalprocedures. The clamps interact with elasticscalp retraction hooks to assist with the self-retaining retraction of the scalp duringneurosurgical procedures. The clamps areoffered in two versions (Snap-On and Slide-On)and each version is offered in two sizes (0.5"and 20mm) to accommodate most commonlyused surgical accessory bars. |
|---|---|
| Intended Use: | The Spetzler Snap-On/Slide-On Scalp RetractorClamps are accessories that are intended to beused to assist in the retraction of the scalpduring all supratentorial and infratentorial skulloperations. |
| Summary of TechnologicalCharacteristics: | The proposed device and the predicate devicesare composed of the same or similar principalsof operation, design, materials andmanufacturing characteristics. |
| Summary of Testing: | The Spetzler Snap-On/Slide-On Scalp RetractorClamps were evaluated in non-clinical testsunder various conditions to assess the designperformance and conformance to designspecifications. |
| Non-Clinical Testing | Performance testing demonstrated that theproposed device is substantially equivalent tothe currently marketed predicate devices withregard to functional characteristics. |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
MAR 1 8 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cardinal Health c/o Gina Rajterowski Regulatory Affairs Manager 1430 Waukegan Road McGaw Park, IL 60085-6787
Re: K090272
Trade/Device Name: Spetzler Snap-On/Slide-On Scalp Retractor Clamps Regulation Number: 21 CFR 882.4800 Regulation Name: Self-retaining retractor for neurosurgery Regulatory Class: Class II Product Code: GZT Dated: March 4, 2009 Received: March 9, 2009
Dear Ms. Rajterowski :
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 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.
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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Sincerely yours,
M. B. Egelston, m.D.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Cardinal Health 1430 Waukegan Road McGaw Park, Illinois 60085-6787 847.578.6442 FAX: 847.785.2506
Indication for Use
510(k) Number (if known):
Device Name:
Spetzler Snap-On/Slide-On Scalp Retractor
Clamps
Indications For Use: The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are accessories that are intended to be used to assist in the retraction of the scalp during supratentorial and infratentorial skull operations.
Prescription Use X
Over-The Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
or
(Division/Sign-Off). Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number
§ 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).