(42 days)
Not Found
No
The device description and intended use describe a mechanical surgical accessory for scalp retraction, with no mention of AI or ML capabilities.
No
Explanation: A therapeutic device is one that treats or prevents a disease or condition. This device is described as a "surgical accessory" that assists in retracting the scalp during neurosurgical procedures; it does not directly treat or prevent a condition.
No
Explanation: The device is described as a surgical accessory designed to assist in scalp retraction during neurosurgical procedures. It does not collect or analyze data to provide a medical diagnosis.
No
The device description clearly states that the device is a physical surgical accessory (clamps) that affixes to surgical bars and interacts with elastic hooks. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Spetzler Snap-On/Slide-On Scalp Retractor Clamps are surgical accessories used during surgery to physically retract the scalp. They do not interact with or analyze any bodily specimens.
- Intended Use: The intended use clearly states they are used to "assist in the retraction of the scalp during all supratentorial and infratentorial skull operations." This is a mechanical function performed on the patient's body, not a diagnostic test on a specimen.
Therefore, based on the provided information, this device falls under the category of a surgical instrument or accessory, not an In Vitro Diagnostic.
N/A
Intended Use / 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 all supratentorial and infratentorial skull operations.
Product codes (comma separated list FDA assigned to the subject device)
GZT
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp during supratentorial and infratentorial skull operations.
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 Spetzler Snap-On/Slide-On Scalp Retractor Clamps were evaluated in non-clinical tests under various conditions to assess the design performance and conformance to design specifications. Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics.
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.
Rhoton-Merz Self-Retaining Brain Retractor System, K895395, Leyla Self-Retaining Brain Retractor System Preamendment device
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).
0
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 Health
1430 Waukegan Road MPKB
McGaw 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 Retractor
Clamps |
| Common Name | Clamp accessory used for self-retaining
retraction |
| Classification Name | Self-retaining retractor for neurosurgery (21
CFR, 882.4800, Product Code GZT) |
| Predicate Device(s) | Rhoton-Merz Self-Retaining Brain Retractor
System, K895395
Leyla Self-Retaining Brain Retractor System
Preamendment device |
1
| Description: | 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. |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended 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 all supratentorial and infratentorial skull
operations. |
| Summary of Technological
Characteristics: | The proposed device and the predicate devices
are composed of the same or similar principals
of operation, design, materials and
manufacturing characteristics. |
| Summary of Testing: | The Spetzler Snap-On/Slide-On Scalp Retractor
Clamps were evaluated in non-clinical tests
under various conditions to assess the design
performance and conformance to design
specifications. |
| Non-Clinical Testing | Performance testing demonstrated that the
proposed device is substantially equivalent to
the currently marketed predicate devices with
regard to functional characteristics. |
. .
.
2
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.
3
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
4
Image /page/4/Picture/0 description: The image contains the logo for Cardinal Health. The logo consists of a stylized graphic element above the text "CardinalHealth". The graphic element appears to be a series of curved lines, possibly representing movement or connectivity. The text is in a simple, sans-serif font.
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