The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.

Device Description

The Minimal Access Spinal Attachment system consists of three basic components: Angled Motor Adaptor (20° Driver Body); Nose-tube/bearing housings; and a vanety of bone dissection tools (cutters").

Angled Motor Adaptor (20° Driver Body): Two designs, one for the Black Max motor and one for MicroMax/XMax and eMax Motors.

The 20° Driver Body is a non-invasive and non-patient contact component of the Minimal Access Spinal Attachment system that connects to the surgical motor. Unlike other attachments, the Minimal Access Spinal Attachment is designed to provide a 3.0mm length adiustment of the nose-tube/bearing sleeves.

The 20° Driver Body is reusable, distributed clean and nonsterile. It is designed to be cleaned with (non-immersion) soapy-water and/or full immersion in isopropyl alcohol. Recommended cleaning and sterilization processes are provided with each device.

Nose tube/bearing sleeves: Four initial tube designs*

1. Long Curved (10+/- 2°)
1. Long Straight
1. Short Curved (10+/- 2°)
1. Short Straight

Additional lengths to become available

The nose-tube/bearing sleeve is reusable, provided it is properly handled, cleaned, and maintained as directions for use (DFU), provided with each product. When increased bearing wear is observed (increased heat and/or noise), the bearing tube is removed from the Driver Body and discarded. A replacement nose-tube is then simply inserted and locked onto the Driver. Like the 20° Driver, nose-tuberbearing sleeves can be steam autoclaved before use in accordance with DFU.

Cutters (Bone Dissection Tools):

Minimal Access Spinal Attachment system cutters are the variety of pre-sterlized, single-use, disposable bone dissection tools. Minimal Access Spinal Attachment cutters are individually packaged and distributed pre-stenlized. A variety of cutting tip designs and diameters in lengths to fit all Nose tube/bearing housings are available with additional sizes and head configurations available in the future.

Cutters are of the same basic design and materials as other currently distributed cutters and are individual packaged and pre-sterilized. Terminal sterilization is achieved by Irradiation to a are interility assurance level (SAL) of 10 . User assembly instructions are provided with each component of the system and also in a variety of catalogs and surgical manuals.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Minimal Access Spinal Attachment system." It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove performance against specific acceptance criteria. This type of submission (510(k)) generally relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria and performance studies for the device itself is not explicitly available in the provided document. The document primarily focuses on establishing substantial equivalence through a comparison of design, materials, and operational characteristics with existing devices.

Here's an analysis based on the available information:

Acceptance Criteria and Study for the Minimal Access Spinal Attachment System

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal quantitative acceptance criteria for the new device's performance (e.g., tensile strength, fatigue life, specific functional percentages). Instead, the "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to existing predicate devices. The device's performance is demonstrated by showing that its characteristics are similar to or better than the predicate devices.

Characteristic	Acceptance Criteria (Implied - substantial equivalence to predicate)	Reported Device Performance (Minimal Access Spinal Attachment)
Use w/Electric motor	Yes (like predicate)	Y
Use w/Pneumatic motor	Yes (like predicate)	Y
Tool-Less attachment	Yes (like predicate)	Y
20° angled driver	Yes (like Anspach MICRO/MDA)	Y
Length adjustable	Yes (like Midas Rex)	Y
Nose tube diameters	Similar to predicate ranges (e.g., 3-5mm)	4-5mm (taper)
Nose tube lengths	Similar to predicate ranges (e.g., 8-16cm+)	7-30cm
Curved nose tube radius	Similar to predicate (e.g., 10° +/- 2°)	10+/- 2°
Cutter shaft diameter	Similar to predicate (e.g., 1.4-1.43mm)	1.4mm
Operating temperature (Max)	≤ 120°C (like predicate)	120°C
Stainless steel construction	Yes (like predicate)	Y
Corrosion resistant bearings	Yes (like predicate)	Y
Immersion cleaning	Possible (like nose-tubes) or not (like 20° Driver)	Y (Nose tubes can be fully immersed. 20° Driver in Isopropyl alcohol)
4 Min flash sterilization	Yes (like predicate)	Y
Sterrad sterilization	Yes (like Anspach MICRO/MDA)	Y
Pre-sterilized cutters	Yes (like predicate)	Y (SAL 10^-6)
Service/Repair (20° Driver)	Yes (like Anspach MICRO/MDA)	Y
Service/Repair (Nose-tubes)	Varies (N for new device, Y for Anspach predicate)	N (designed for disposal when worn)
Service/Repair (Cutters)	No (like predicate)	N

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a traditional "test set" in the context of clinical or performance testing with a specific sample size. The substantial equivalence argument is based on design, materials, and operational characteristics comparison to legally marketed predicate devices.

Sample Size for Test Set: Not applicable in the context of this 510(k) submission. The comparison is between the proposed device and specified predicate devices.
Data Provenance: The data comes from the design specifications and declared characteristics of the Minimal Access Spinal Attachment system, compared against publicly available or manufacturer-provided information for the predicate devices (Anspach Angled Micro-nose Attachment and Medtronic (Midas Rex) "Micro-Telescoping System"). This is inherently retrospective in the sense that it's a review of existing device information and new device design. The country of origin data is also not specified for the predicates, though the submitting company (The Anspach Effort) is US-based (Florida).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. This is not a study requiring expert consensus on a test set of data (e.g., image interpretation). The "ground truth" for the comparison is the published specifications and operating characteristics of the predicate devices and the design specifications of the new device.

4. Adjudication Method for the Test Set:

Not applicable. There was no "test set" in the sense of clinical or performance data requiring adjudication. The comparison is based on technical specifications. The FDA's review process itself acts as an adjudication of whether the substantial equivalence argument is valid.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic or interpretive devices involving human readers, which is not the nature of this surgical attachment.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a mechanical surgical attachment, not an algorithm. Its function inherently involves a human operator (surgeon).

7. The Type of Ground Truth Used:

The "ground truth" for this 510(k) pertains to the design specifications, material properties, and intended functional characteristics of the Minimal Access Spinal Attachment system and the predicate devices. This involves engineering specifications and the declared features of the devices. It does not involve patient outcomes data or pathology results in the context of proving the device's performance.

8. The Sample Size for the Training Set:

Not applicable. The "Minimal Access Spinal Attachment system" is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable, as there is no training set for this type of device.

Summary

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Specialty Attachment 510(k) SUMMARY: -Minimal Access Spinal Attachment system

KO4 2783 CLASSIFICATION: US Class II

PERFORMANCE STANDARDS:

No known performance standards.

DESIGN, MATERIALS AND OPERATION CHARACTERISTICS:

The Minimal Access Spinal Attachment system consists of three basic components: Angled Motor Adaptor (20° Driver Body); Nose-tube/bearing housings; and a vanety of bone dissection tools (cutters").

Angled Motor Adaptor (20° Driver Body): Two designs, one for the Black Max motor and one for MicroMax/XMax and eMax Motors.

Nose tube/bearing sleeves: Four initial tube designs*

1. Long Curved (10+/- 2°)
1. Long Straight
1. Short Curved (10+/- 2°)
1. Short Straight

Additional lengths to become available

Cutters (Bone Dissection Tools):

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lengths to fit all Nose tube/bearing housings are available with additional sizes and head configurations available in the future.

RISK ASSESSMENT:

Risk assessment has been accomplished for the Minimal Access Spinal Attachment system. All identified risks and hazards associated with design, production, performance and use of the Minimal Access Spinal Attachment system were capable of being reduced to acceptable levels through design, process and/or labeling activities.

INDICATIONS / CONTRAINDICATIONS:

Anspach manufactured equipment is contraindicated for surgical use by anyone not qualified through education and experience, in proper use of Anspach product.

CLEANING/STERILIZATION/MAINTENANCE:

Cleaning, sterilization and maintenance instructions are provided in product use manuals available to all purchasers and Instructions (directions) For Use (IFU/DFU) that accompany each product. Unauthorized repairs and maintenance can be grounds for termination of warranty benefits.

WARNINGS and CAUTIONS:

Generic Warnings for use of Anspach products are specified in manuals and on product inserts. For safe and effective use of any Anspach product, specialized training is required as surgical techniques are highly specialized procedures. Improper surgical technique or improper use of product can cause injury or death to a user or patient and damage to product.

SUBSTANTIAL EQUIVALENCE:

The Minimal Access Spinal Attachment system is substantially equivalent to the Anspach Angled Micro-nose Attachment and the Medtronic (Midas Rex) "Micro-Telescoping System". See attached comparison chart on the following page:

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	AnspachMinimal Access	AnspachMICRO/MDA	Midas*Rex
Use w/Electric motor1	Y	Y	Y
Use w/Pneumatic motor1	Y	Y	Y
Tool-Less attachment	Y	Y	Y
20° angled driver	Y	Y	N
Length adjustable	Y	N	Y
Nose tube diameters	4-5mm (taper)	3-4mm	5.0mm
Nose tube lengths	7-30cm	16cm	8-15cm
Curved nose tube radius	10+/- 2°	N	10° 2
Cutter shaft diameter	1.4mm	1.43mm	1.4mm
Operating temperature(Max)	120°	120°	120°2
Stainless steel construction	Y	Y	Y
Corrosion resistant bearings	Y	Y	?
Immersion cleaning	Y3	N	N
4 Min flash sterilization**	Y	Y	Y
Sterrad sterilization	Y	Y	?
Pre-sterilized cutters (SAL106)	Y	Y	Y
Service/Repair (20° Driver)	Y	Y	?2
Service/Repair (Nose-tubes)	N4	Y	?2
Service/Repair (Cutters)	N	N	?2

Medtronic, Midas Rex "Legend"™ Micro-Telescoping System

** Flash sterilization is only recommended for immediate use in the operating theater.

1 Anspach product compatible with Anspach product only.

2 Information provided should be considered average or unknown (?), as it is unknown what level of design, production or performance controls are established for specific devices.
3 Nose tubes may be fully immersed. 20° Driver is designed for full immersion in Isopropyl alcohol during cleaning processes for sterilization and reuse, but continues to be labeled "Do not Immerse" to prevent immersion in saline or other fluids while in the surgical theater.
4 Nose-tubes are designed for reuse until bearing wear (heat/noise) becomes noticeable, at which time nose-tubes should be disposed of.

End Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

Mr. William G. Conety Director, Regulatory Affairs and Ouality Assurance The Anspach Effort 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K042783

Trade/Device Name: Minimal Access Spinal Attachment System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: December 8, 2004 Received: December 10, 2004

Dear Mr. Conety:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease, 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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Page 2 - Mr. William G. Conety

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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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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510(k) Number: K (542783

Page 1 of 1

Device Name: Minimal Access Spinal Attachment system

INDICATIONS FOR USE:

Prescription Use: _ × (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

510(k) Number_ K04 2783

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).