(55 days)
Not Found
No
The device description and intended use focus on mechanical components for surgical access, with no mention of AI/ML terms or image processing.
No.
The device is a surgical retractor system used to hold wound edges open and provide access during minimally invasive spinal procedures; it does not directly treat a disease or condition.
No
Explanation: The device is described as a "self-locking device to hold the edges of a wound open" and "dilators, tubular retractors... for use in providing access to the spine." These are tools for surgical procedures (retraction and access), not for diagnosing conditions.
No
The device description clearly states it is a series of physical dilators, tubular retractors, and a guide wire, which are hardware components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures." This describes a surgical tool used during a procedure on a patient's body.
- Device Description: The description details "dilators, tubular retractors... and guide wire for use in providing access to the spine." These are also surgical instruments used for physical manipulation during a procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health status, diagnose conditions, or monitor treatment. The provided information does not mention any such use or interaction with biological specimens.
Therefore, this device falls under the category of a surgical instrument or retractor, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
To provide the surgeon with minimally invasive surgical 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 a microscope and surgical instruments can be manipulated.
Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.
Product codes
GZT
Device Description
Series of dilators, tubular retractors of various lengths and guide wire for use in providing access to the spine for minimally invasive discectomy procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Spine
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)
When used as designed, the Dilation Retractor System functions in as safe and effective a manner as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Sofamor Danek MicroEndoscopic Discectomy Retractor System
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
OCT 21 1999
.
Page 10
ﺴﻬ
SECTION 6
510(k) SUMMARY
| Submitter's Name: | Bright Medical Instruments |
|---|---|
| Submitter's Address: | 799 N.E. 71st Street |
| Boca Raton, Florida 33467 | |
| Contact Person: | Robert E. Simonson |
| Telephone: | 877-527-4448 |
| Facsimile: | 561-998-8224 |
| Date Prepared: | July 30, 1999 |
| Device Trade Name: | Dilation Retractor System |
| Device Common Name: | Surgical Retractor |
| Classification Name: | Self-Retaining Retractor for Neurosurgery |
| Predicate Device: | Sofamor Danek MicroEndoscopic |
| Discectomy Retractor System | |
| Device Description: | Series of dilators, tubular retractors of |
| various lengths and guide wire for use in | |
| providing access to the spine for | |
| minimally invasive discectomy | |
| procedures. | |
| Intended Use: | To provide the surgeon with minimally |
| invasive surgical 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 a microscope | |
| and surgical instruments can be | |
| manipulated. |
1
Page 11
| Technological Characteristics
and Comparison to Predicate | The Bright Medical Dilation Retractor
System is manufactured from equivalent
materials, with similar dimensions, to
achieve the same surgical objectives as
the predicate MED MicroEndoscopic
Discectomy System. |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | When used as designed, the Dilation
Retractor System functions in as safe
and effective a manner as the predicate
device. |
| Conclusion: | The Bright Medical Dilation Retractor
System is safe and effective and is
substantially equivalent to the predicate
device. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 image of three wavy lines, resembling a bird in flight or a symbolic representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1999
Mr. Robert E. Simonson President Bright Medical Instruments 799 North East 71st Street Boca Raton, Florida 33487
Re: K992898
Trade Name: Bright Medical Dilation Retractor System Regulatory Class: II Product Code: GZT Dated: July 29, 1999 Received: August 27, 1999
Dear Mr. Simonson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 - Mr. Robert E. Simonson
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 9
K992898
SECTION 5
INDICATIONS FOR USE
Bright Medical Dilation Retractor System
Provide a self-locking device to hold the edges of a wound open for neurosurgical procedures.
Prescription Use __
or
Over the Counter _______________
Poole Jo
(Division Sign-Off) Division of General Restorative Devices 128 510(k) Number