(144 days)
Not Found
No
The device description and intended use clearly define it as a manual surgical instrument with mechanical components. There is no mention of AI, ML, image processing, or any data-driven functionalities.
No
The device is described as a specialized manual surgical instrument intended for providing access during surgical procedures, which are assistive tools for medical procedures rather than devices that directly confer a therapeutic effect.
No
The device is described as a specialized manual surgical instrument intended to provide access during surgical procedures, not to diagnose a condition or disease.
No
The device description clearly states it is a "specialized manual surgical instrument" with physical components like retractors, handles, and forceps. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "specialized manual surgical instrument" for providing access to the spinal column during surgical procedures. This is a surgical tool used in vivo (within the body), not for testing samples in vitro (outside the body).
- Device Description: The description lists components like retractors, handles, and forceps, which are all surgical instruments used directly on the patient during surgery.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, this device falls under the category of a surgical instrument, not an IVD.
N/A
Intended Use / Indications for Use
The device is intended for use as a specialized manual surgical instrument. It is reusable and is intended to provide access to the anterior thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system with inflatable tissue protectors.
Product codes (comma separated list FDA assigned to the subject device)
HRX, GZT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior thoracic and lumbar spinal column
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician only, healthcare facilities and physicians
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)
Not Found
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.
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
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.
0
APR 2 7 2001
Koo3740
afety and Eff Section 510(k) PRICE 2001 narket Nothcation.
Safe Medical Devices Act of 1990, 21 CFR 807.92 Regulatory Authority:
miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Trade Name:
Spinal retractor Common Name(s):
Classification Name(s):
Spinal retractor, self-retaining retractor for neurosurgery
Establishment Name & Registration Number:
Name: Aesculap® Inc. 2916714 Number:
Classification(s):
& 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).
Device Class: Classification Panel: Product Code(s):
Class II for the requested indications Orthopaedic and Neurosurgery Devices Panel HRX, GZT
Applicant Name & Address:
Aesculap® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.876.7000 voice - 650.876.0266 fax
Company Contact:
Ms. Joyce Thomas Aesculan® Inc. 944 Marcon Blvd. Allentown, PA 18109 650.876.7000 voice - 650.876.0266 fax
Submission Correspondent:
Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C - 100 Pleasant Hill, CA 94523-3389 925.356.2640 - 925.356.2654 - fax
Labeling:
The miaspass miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation discussed in this summary is made in Germany by AESCULAR® AG & CO. KG. The system will be marketed exclusively to healthcare facilities and physicians.
1
Koo 3740
201=2
Surgical Technique. The surgical approach used with the miaspas® min1TTA Anterior Micro Surgical Transthoracic Approach Instrumentation is similar to other spirial retractor systems and instruments.
Warning: Federal (United States) Law restricts this device to sale by or on the order of a physician only.
Preaments Device (legally marketed comparison device):
AESCULAP® Inc. believes that the milaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is substantially equivalent to the following spinal retractors marketed by Surgical Dynamics, Inc. and Brigfht Medical Instruments.
- Surgical Dymanics Spinal Retractor K002008, Surgical Dynamics, Inc. .
- Hever- Shulte Corporation, K780706, Lumbar Nerve Root Shield .
- Dilation Retractor System K992898, Bright Medical Instruments, Inc. .
To facilitate comparison of the maspas® miniTTA Anterior Micro Surgical Transthoratic Approach Instrumentation to the systems identified above, a basic feature companson table is located at the end of the document.
Summary Basis for Equivalence and Comparison Table:
- The devices have the same intended use and/or indications for use. ●
- The devices are made of comparable instrument grade materials. .
- . The devices have similar function, surgical approach, instruments and features.
The use of ISO & QSR based process controls and the similarities of the references companson devices establish that the milaspass miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is substantially equivalent to available legally marketed spinal retractors. It is believed that the anticipated clinical performance of the miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is equivalent to the referenced systems.
| FEATURE | miaspas® miniTTA Anterior Micro Surgical
Transthoracic Approach Instrumentation | Surgical Dynamics
retractor | Bright Medical Dilation retractor
System | SE? |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|
| Indications
for Use: | The device is intended for use as a
specialized manual surgical instrument.
It is reusable and is intended to provide
access to the anterior thoracic and
lumbar spinal column during minimally
invasive and endoscopic surgical
procedures. Provides a self-locking type
surgical retraction system with inflatable
tissue protectors. | Hollow rigid instrument for
use in spine surgery for
viewing and instrument
access to the vertebral
space. Retracts tissue
during open and endoscopic
procedures. | Dilators, tubular retractors &
guide wires used to provide
minimally invasive surgical
access to the spine.
Positioned down to the
surface of the spine using
self-locking flexible arm. | YES |
| Components: | Tray, retractor, counter retractor, lung
retractor, rib retractor Sm. & Lg.,
diaphragm retractor Sm., Med., Lg.,
Lung retractor w/ inflatable cuff Sm.,
Med., Lg., handle for retractor blades,
forceps for retractor blade & drape. | 3 sizes | 5 dilators, 3 tubular
retractors, 1 guidewire,
flexible attachment arm. | YES |
| Sterilization: | Steam autoclave | Same | Same | YES |
| Materials: | Titanium alloy | Stainless steel | Stainless Steel | YES |
| | | | | YES |
| Manufacturer | Aesculap | Surgical Dynamics, Inc. | Bright Medical, Inc. | YES |
| Surgical
Approach: | Transthroacic | Lateral/transthoracic | Lateral/transthoracic | YES |
| Product
Code: | GZT. HRX | GZT, HRX | GZT | YES |
| K - Number: | Pending | K002008 | K992898 | YES |
Summary Comparison Table:
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
APR 2 7 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aesculap, Inc. c/o Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory lane Suite C-100 Pleasant Hill, California 94523
Re: K003740
Trade/Device Name: miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Regulation Number: 888.1100, 882.4800 Regulatory Class: II Product Code: HRX, GZT Dated: February 7, 2001 Received: March 12, 2001
Dear Mr. Schlerf:
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 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). 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 requirements, 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. David W. Schlerf
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) 594-4659. 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" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Mark N Milkan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1
510(k) Number: K003740
IIIIIaSDas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation Device Name(s):
Indications for Use:
Self-retaining retractor for neurosurgery & Spinal retractor
The device is intended for use as a specialized manual surgical instrument. It is reusable and is intended to provide access to the anterior thoracic and lumbar spinal column during minimally invasive and endoscopic surgical procedures. Provides a self-locking type surgical retraction system with inflatable tissue protectors.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millican
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K003740
Over-The-Counter Use
(Optional format 1-2-96)
Prescription Use
(Per 21 CFR 801.109)
OR