The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system. The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism. The Anspach Helix™ Dissection Tools are provided sterile.

AI/ML Overview

This document is a 510(k) summary for the Anspach Helix™ Dissection Tools, which are intended for cutting and shaping bone, including the spine and cranium. The submission demonstrates substantial equivalence to a predicate device (K113476).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Verification Analysis - Mating Clearance & Anti-Rotation Interference	Mating clearance and anti-rotation interference when engaged with drive spindle of EG1, XMAX, & EMAX2PLUS handpieces. (Design output meets design input.)	The analysis shows that the design output meets the design input; the proposed Helix dissection tools drive feature meets the acceptance criteria of mating clearance and anti-rotation interference when engaged with drive spindles of EG1, XMAX, & EMAX2PLUS handpieces.
Helix Dissection Tool and Attachment Compatibility - Shaft Diameter/Shaft Length	Minimum and maximum clearance between the shaft diameter of the dissection tool and inner race bearing diameter of the attachment must be within the required range. Minimum length in the lock position exists to prevent interference. Tapered section of the dissection tool does not interfere with the distal bearing inner diameter of the attachment.	Analysis confirmed compatibility. Tolerance analysis reflects 0.0001 to 0.0007 inches of clearance between dissection tools and the attachment, which is in the required range for a 3/32-inch shaft diameter and compatible attachments. Tolerance analysis reflects that the minimum length in the lock position exists and the tapered section will not interfere with the distal bearing inner diameter of the attachment.
Helix Ball Bur Chatter/Cut and Shape Verification Report	Chatter: The % chatter for each group of same-size Helix ball burs must be less than the chatter of the corresponding group of same-size predicate G1 burs, as determined by a hypothesis test with a significance level (alpha) = 0.10.	All samples met the acceptance criteria and exhibited statistically lower % chatter than the corresponding same size predicate devices, with the exception of the S-25SB-HX-G1-1. For this specific size, while lower, the results were not statistically significant as compared to the corresponding same size predicate.
	Cutting and Shaping: Each Helix ball bur used to cut into Bi-resin (simulated bone) samples shall be evaluated to confirm that they cut and shape bone the same as the predicate.	All samples met the acceptance criteria to cut and shape bone, the same as the predicate.
	Cutter Head Fracture: Each Helix ball bur used to cut into Bi-resin (simulated bone) samples shall be visually inspected for cutter head fracture, with the acceptance criteria of the bur head intact on the cutter and not broken, the same as the predicate.	All samples met the acceptance criteria for the head of the cutter to remain intact, the same as the predicate.
Biocompatibility Testing	Meet requirements per FDA guidance document Use of International Standard ISO 10993-1.	The Anspach Helix™ Dissection Tools are manufactured and packaged in the same manner with identical material as the predicate device (K113476). No new or additional processing steps were introduced, therefore, biocompatibility requirements have been met by reference to the predicate.

Study Details for Meeting Acceptance Criteria:

The document describes design verification activities rather than a standalone clinical study involving human patients or a multi-reader, multi-case study. The testing focused on technical and performance characteristics compared to a predicate device.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a single number for all tests. For the Helix Ball Bur Chatter/Cut and Shape Verification, it mentions "each group of same-size Helix ball burs" and "Each Helix ball bur used to cut into the Bi-resin samples." This implies multiple burs were tested across different sizes. However, specific quantities (e.g., "n=X burs per size") are not provided.
Data Provenance: The tests utilized simulated bone (Bi-resin) and a tolerance analysis. This is laboratory-based data, not human patient data. There is no country of origin for data as it's not a clinical study. It's prospective in the sense that these tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This was not a study requiring expert readers or ground truth established by medical professionals. The "ground truth" was based on engineering specifications, physical measurements, and comparison to the performance of the predicate device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No expert adjudication was described for these engineering and performance tests. The acceptance criteria were objectively defined (e.g., statistical significance for chatter, visual inspection for fracture, tolerance ranges).

5. 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:

No, an MRMC comparative effectiveness study was not done. This device is a surgical tool, not an AI-powered diagnostic or assistive technology.

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

Not applicable. This device is a manual surgical tool that requires human operation; it is not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For technical specifications (mating, compatibility): Engineering tolerance analysis and physical measurements.
For performance (chatter, cut and shape, fracture): Quantitative measurements for chatter (statistical comparison to predicate) and visual inspection against a predicate device for cutting/shaping and integrity.
The predicate device's established performance served as a de facto "ground truth" for comparison.

8. The sample size for the training set:

Not applicable. This device did not involve a training set as it is not an AI/machine learning system.

9. How the ground truth for the training set was established:

Not applicable. There was no training set.

Summary

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The Anspach Effort, Inc. Tamara West Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, Florida 33410

Re: K183545

Trade/Device Name: Anspach Helix Dissection Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: June 14, 2019 Received: June 17, 2019

Dear Tamara West:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

Device Name

Anspach Helix™ Dissection Tools

Indications for Use (Describe) Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

I. SUBMITTER

The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, Florida 33410 USA

Registration Number: 1045834

Contact: Tamara West Phone: (561) 494-3712 Fax: (561) 624-8383 Email: twest1@its.jnj.com

Alternate Contact: Jeannette G. Dailey Phone: (561) 494-3710 Fax: (561) 624-8383 Email: jdailey5@its.jnj.com

Date Prepared: June 14, 2019

II. DEVICE

Trade Name: Anspach Helix™ Dissection Tools

Common Name: Dissection Tools

Classification Information: 21 CFR 882.4310 Drills, burs, trephines, and accessories (simple, powered)

Regulatory Class: II

Product Code: HBE

Classification panel: Neurology

III. PREDICATE DEVICE

K113476 Dissection Tools Owner: The Anspach Effort, Inc.

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IV. DEVICE DESCRIPTION

The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism.

The Anspach Helix™ Dissection Tools are provided sterile.

V. INDICATIONS FOR USE

Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.

	Anspach Helix™ Dissection Tools	Dissection Tools
510(k) Number	K183545	K113476
Indications for Use	Anspach Helix™ Dissection Tools are used for cutting and shaping bone including the spine and cranium.	Dissection tools are intended for cutting shaping bone including the spine and cranium.
Product Code	HBE	HBE
Class	2	2
Sterilization	Gamma irradiated	Gamma irradiated
SterilizationAssurance Level(ASL)	10-6	10-6
TECHNOLOGICAL CHARACTERISTICS
Head Styles	Fluted Ball	Fluted Ball, Fluted Matchstick,Diamond Ball
Flutes	2 Flutes	2 Flutes (Matchstick)4 – 12 Flutes (Ball)
Head Diameter	2mm – 7mm	Fluted Ball:0.5mm – 9mm
Material	M2 Tool Steel	M2 Tool Steel, Stainless Steel,Carbide, Diamond coated
Locking mechanism	Diamond Flat Configuration	Diamond Flat Configuration
Labeling	Sterile, single-use	Sterile, single-use

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33

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PackagingConfiguration	PETG tray in a sealed Tyvek pouchplaced into a carton	PETG tray in a sealed Tyvek pouch
Shelf life	5 years	5 years

The predicate dissection tools (K113476) are part of an electric/pneumatic drill system and are available in many different styles and dimensions, including a fluted ball. A minor design modification was made to the head of the existing fluted ball style by offering a 2fluted style as compared to 4 or more flutes with the predicate device. The 2-fluted style was developed to provide a dissection tool that produces less chatter and vibration while cutting than the predicate dissection tools (K113476).

The proposed Anspach Helix™ Dissection Tools remain identical to the predicate dissection tools (K113476) in terms of operating principles, where it attaches to the handpiece/attachment of either an electric or pneumatic drill utilizing the diamond flat locking mechanism. The indications for use, material and manufacturing remain identical to the predicate dissection tools (K113476).

The technological characteristics of the proposed Anspach Helix™ dissection tools are similar to those of the predicate (K113476) device in the following ways:

Both dissection tools use a patented locking mechanism on the distal end to secure to the handpiece
· Both dissection tools are compatible with the same electric and pneumatic drill systems, including attachments
Both dissection tools have a straight shaft and fluted ball style head, where the proposed dissection tools have 2 flutes opposed to 4 or more flutes of the predicate dissection tools
· Both dissection tools are provided sterile

As with the predicate dissection tools (K113476), the Anspach Helix™ Dissection Tools have no impact on the safety and effectiveness of the device or the ability to perform as intended.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing:

The Anspach Helix™ dissection tools are classified as external communicating devices: tissue/bone/dentin with limited patient contact (< 24 hours).

A biocompatibility evaluation was conducted for the Anspach Helix™ Dissection Tools per the FDA guidance document Use of International Standard ISO 10993-1. "Biological

Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33410

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evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".

The Anspach Helix™ Dissection Tools are manufactured and packaged in the same manner with identical material as the predicate device (K113476). No new or additional processing steps were introduced; therefore, biocompatibility requirements have been met.

Design Control:

The following verification activities were performed to demonstrate that the device meets the performance requirements under its indications for use conditions for determination of substantial equivalence.

Test	Test Method Summary	Results
Verification Analysis - MatingClearance & Anti-RotationInterference	Conduct a tolerance analysis todetermine that there is matingclearance and anti-rotationinterference when engaged withdrive spindle of EG1, XMAX, &EMAX2PLUS handpieces	The analysis shows that thedesign output meets the designinput; the proposed Helixdissection tools drive featuremeets the acceptance criteria ofmating clearance and anti-rotation interference whenengaged with drive spindles ofEG1, XMAX, & EMAX2PLUShandpieces.
Helix Dissection Tool andAttachment Compatibility - ShaftDiameter/Shaft Length	Conduct a tolerance analysis todetermine the minimum andmaximum clearance between theshaft diameter of the dissectiontool and inner race bearingdiameter of the attachment.	Analysis was performed byevaluating all Helix dissectiontools and attachment (predicate)combinations to confirmcompatibility.Tolerance analysis reflects 0.0001to 0.0007 inches of clearancebetween dissection tools and theattachment which is in therequired range of scope with a3/32-inch shaft diameter and theinner race bearing diameter ofcompatible attachments as listedin the compatibility table.Tolerance analysis reflects thatthe minimum length in the lockposition exists, so the head willnot interfere with the attachment.Tolerance analysis reflects thatthe tapered section of thedissection tool will not interferewith the distal bearing innerdiameter of the attachment.

Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33410

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Helix Ball Bur Chatter/Cut andShape Verification Report
	The % chatter for each group ofsame-size Helix ball burs mustbe less than the chatter of thecorresponding group of same-size predicate G1burs, as determined by ahypothesis test with asignificance level (alpha) = 0.10.	All samples met the acceptancecriteria and exhibited statisticallylower% chatter than thecorresponding same sizepredicate devices with theexception of the S-25SB-HX-G1-1.For this size, while lower, theresults were not statisticallysignificant as compared to thecorresponding same sizepredicate.
	Each Helix ball bur used to cutinto the Bi-resin (simulatedbone) samples and then shall beevaluated to confirm that theycut and shape bone the same asthe predicate.	All samples met the acceptancecriteria to cut and shape bone,the same as the predicate.
	Each Helix ball bur used to cutinto the Bi-resin (simulatedbone) samples and then shall bevisually inspected for cutter headfracture with the acceptancecriteria of the bur head intact onthe cutter and not broken, thesame as the predicate.	All samples met the acceptancecriteria for the head of the cutterto remain intact, the same asthe predicate.

The above verification activities demonstrate the Anspach Helix™ Dissection Tools perform as intended in cutting and shaping bone in the same manner as the predicate (K113476) and are compatible with existing predicate devices (K113746). Verification activities also demonstrate that select Helix designs exhibited statistically significantly lower chatter and vibration while cutting than the corresponding same size burs of the predicate devices (K113476). Based on the results of the verification activities, the proposed Anspach Helix™ Dissection Tools are determined to be substantially equivalent to the predicate devices (K113476).

No animal or clinical testing was necessary for a determination of substantial equivalence.

VII. CONCLUSIONS

The Anspach Helix™ Dissection Tools described in this submission have the same intended use, general design, material, technological characteristics, and principles of operation as the predicate device (K113476) and do not raise any new issues of safety or efficacy. In addition, the select 2-flute designs that are part of the marketing claims within this submission also do not raise any new issues of safety or efficacy and were found to be substantially equivalent to the predicate devices (K113476). Therefore, the proposed Anspach Helix™ Dissection Tools are found to be substantially equivalent to the predicate devices.

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).