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.

Device Description

The miaspas® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation is a specialized manual surgical instrument. It is reusable and provides a self-locking type surgical retraction system with inflatable tissue protectors. Components include 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.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called the "miaspass® miniTTA Anterior Micro Surgical Transthoracic Approach Instrumentation." This document focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the way you've outlined.

Therefore, I cannot provide the information in the requested format because the document does not contain a study that proves the device meets specific acceptance criteria with quantifiable performance metrics.

Instead, the document asserts substantial equivalence based on:

Same intended use and/or indications for use.
Comparable instrument grade materials.
Similar function, surgical approach, instruments, and features.
Use of ISO & QSR based process controls.

The only "comparison" is a table comparing features with predicate devices, but this is not a study measuring performance against pre-defined acceptance criteria.

Here's a breakdown of why this information is not present in the provided text:

A table of acceptance criteria and the reported device performance: Not present. The document argues for substantial equivalence based on design and functional similarities to predicate devices, not on meeting specific, quantifiable performance thresholds in a test.
Sample size used for the test set and the data provenance: Not applicable, as no performance testing study is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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: Not applicable. This device is a surgical instrument, not an AI-powered diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission establishes substantial equivalence through a comparison of device features and intended use with predicate devices, not through a performance study against specific acceptance criteria.

Summary

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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.

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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 SurgicalTransthoracic Approach Instrumentation	Surgical Dynamicsretractor	Bright Medical Dilation retractorSystem	SE?
Indicationsfor Use:	The device is intended for use as aspecialized manual surgical instrument.It is reusable and is intended to provideaccess to the anterior thoracic andlumbar spinal column during minimallyinvasive and endoscopic surgicalprocedures. Provides a self-locking typesurgical retraction system with inflatabletissue protectors.	Hollow rigid instrument foruse in spine surgery forviewing and instrumentaccess to the vertebralspace. Retracts tissueduring open and endoscopicprocedures.	Dilators, tubular retractors &guide wires used to provideminimally invasive surgicalaccess to the spine.Positioned down to thesurface of the spine usingself-locking flexible arm.	YES
Components:	Tray, retractor, counter retractor, lungretractor, 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 tubularretractors, 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
SurgicalApproach:	Transthroacic	Lateral/transthoracic	Lateral/transthoracic	YES
ProductCode:	GZT. HRX	GZT, HRX	GZT	YES
K - Number:	Pending	K002008	K992898	YES

Summary Comparison Table:

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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.

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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

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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

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)

Regulation Number and Section

§ 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.