When used with the ANSPACH Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

Device Description

The OCM-G1 (Otologic Curved Micro) Attachment is an accessory to the G1 electric drill system. It is a one-piece straight attachment that is manufactured from 17-4PH and 303 stainless steels (ASTM A564 and ASTM A582). The OCM-G1 Attachment can be connected and disconnected to the distal end of the handpiece via a locking mechanism by the user. After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies. The OCM-G1 Attachment is provided non-sterile and is reusable.

AI/ML Overview

This document describes the OCM-G1 Attachment, an accessory for surgical drills used in otology procedures. The submission is a 510(k) premarket notification, indicating a comparison to a predicate device demonstrating substantial equivalence.

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

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance and How it Meets Criteria
Biocompatibility	Criterion: Biocompatibility according to FDA guidance (ISO 10993-1) for devices with indirect or no patient contact.
	Performance: The OCM-G1 Attachment does not have direct or indirect patient contact, similar to the predicate. It is manufactured with identical material and processing as the predicate. Thus, biocompatibility requirements have been met by demonstrating similarity to the predicate and existing evaluation.
Functional Performance	Criterion: Proper functionality, compatibility, safe external temperatures, and ability to connect and disconnect without tools. Performance in cutting and shaping bone as intended.
	Performance: - Locking feature compatibility: Tested and demonstrated. - Temperature: Tested and demonstrated safe external temperatures. - Disconnect without tools: Tested and demonstrated. - System functionality: Tested and demonstrated proper functionality. - Simulated use study: Demonstrated the OCM-G1 Attachment and curved cutting burrs perform as intended in cutting and shaping bone, similarly to the predicate.
Cleaning and Reprocessing	Criterion: Ability to be cleaned and sterilized effectively to achieve a Sterility Assurance Level (SAL) of 10^-6 without adverse effects.
	Performance: The OCM-G1 Attachment's characteristics are considered equal to or less challenging to sterilize than the currently validated "worst case" predicate device. This implies that existing validated cleaning and sterilization processes are capable of achieving the required SAL.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the test sets in the performance data section. The performance data seems to be based on bench testing and simulated use studies rather than clinical data from human subjects.

Provenance: All testing appears to be internal verification and validation conducted by the manufacturer, The Anspach Effort, Inc., or its affiliates. No information is provided about the country of origin for the data or whether it was retrospective or prospective in a clinical context, as clinical testing was not performed or deemed necessary.

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

This information is not provided. Given that the testing included bench tests and a simulated use study, the "ground truth" would likely be defined by engineering specifications, performance standards, and the intended use of the device, rather than expert clinician consensus on patient data.

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

Not applicable. This type of adjudication method is typically used in clinical studies involving multiple readers evaluating medical images or diagnoses against a predefined ground truth. The studies described are engineering verification tests and a simulated use study, which would not involve such a method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices. The OCM-G1 Attachment is a mechanical surgical handpiece accessory, not an AI device.

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

Not applicable. The OCM-G1 Attachment is a mechanical device, not an algorithm, so a standalone algorithm performance study is not relevant. Its performance is always in conjunction with a human operator and other surgical system components.

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

The "ground truth" for the performance data appears to be based on:

Engineering Specifications and Standards: For tests like locking feature compatibility, temperature, disconnect without tools, and system functionality. These are likely evaluated against predefined design requirements and industry standards.
Intended Use Performance: For the simulated use study, the ground truth is the successful cutting and shaping of bone as intended for otology procedures, evaluated by direct observation and measurement against expected outcomes.
Predicate Device Equivalence: A significant part of the submission relies on demonstrating that the device performs "the same as the predicate (K131053)" in various aspects, implying the predicate's established safety and effectiveness serve as a practical ground truth.

8. The sample size for the training set

Not applicable. The OCM-G1 Attachment is a mechanical device, not an AI or machine learning algorithm, and therefore does not have a "training set."

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

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

Summary

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March 27, 2018

The Anspach Effort, Inc. Tamara West Sr. Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, FL 33410

Re: K180063

Trade/Device Name: OCM-G1 Attachment Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, nose, and throat electric or pneumatic surgical drill Regulatory Class: Class II Product Code: ERL Dated: February 27, 2018 Received: February 28, 2018

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. 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.

U.S. Food & Drug Administration 10903 New Hampshire Avenue

Silver Spring, MD 20993 www.fda.qov

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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); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180063

Device Name Anspach OCM-G1 Attachment

Indications for Use (Describe)

When used with the ANSPACH® Systems, the OCM-G1 Attachment and Burr Support Sleeves are intended for cutting and shaping bone primarily in otology procedures such as cocleostomies.

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

[ Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: January 02, 2018

II. DEVICE

Trade Name: OCM-G1 Attachment

Common Name: Surgical Cutting Tools

Classification Information: 874.4250 Drill, Surgical, ENT (Electric or Pneumatic) Including Handpiece

Regulatory Class: II

Product Code: ERL

Classification panel: Ear, Nose and Throat

III. PREDICATE DEVICE

K131053 Anspach XMax Pneumatic and eMax 2 Plus Electric Systems with Otologic Attachment System (Otologic Attachment and Curved Burrs)

Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 334

Phone (561) 627-1080 · Fax (561) 627-312 Toll Free Phone (800) 327-6887 · Toll Free Fax (800) 327-6661

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IV. DEVICE DESCRIPTION

After the OCM-G1 Attachment is secured to the handpiece, it will accept and hold an OCM curved burr support sleeve assembly (previously cleared). The OCM curved burr support sleeve assembly will rotate at a speed selected by the user for cutting and shaping bone, primarily in otology procedures such as cochleostomies.

The OCM-G1 Attachment is provided non-sterile and is reusable.

V. INDICATIONS FOR USE

When used with the ANSPACH Systems, the OCM-G1 Attachment is intended for culting and shaping bone primarily in otology procedures such as cochleostomies.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

	OCM-G1 Attachment	eMax 2 Plus Electric Systems withOtologic Attachment System (OtologicAttachment and Curved Burrs)
510(k)Number	K180063	K131053
Indicationsfor Use	When used with the ANSPACH Systems,the OCM-G1 Attachment is intended forcutting and shaping bone primarily inotology procedures such ascochleostomies.	When used with the ANSPACH Systems, theOCM Attachment and OCM Burr SupportSleeves are intended for cutting andshaping bone primarily in otologyprocedures such as cochleostomies.
Sterilization	Non-sterile	Non-sterile
Product Code	ERL	ERL, EQJ
Dissection Tools - NA
Console - NA
Handpiece - NA
Foot Control - NA
Attachment
Description	Same	Straight Attachment
LockingMechanism	Diamond Flat configuration	560 Flat configuration
Material	Same	Stainless Steel
Length	2.5mm	2.6mm
Knurl sleeve	Yes	No
Connection to	Same	Quick Disconnect

Anspach Companies

4500 Riverside Drive, Palm Beach Gardens, Florida 33

Phone (561) 627-1080 · Fax (561) 627-3120 Toll Free Phone (800) 327-6887 · Toll Free Fax (800) 327-6661

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handpiece
Labeling	Same	Non-sterile

The predicate OCM Attachment (K131053) is an accessory to an electric/pneumatic handpiece that utilizes the 560 Flat configuration locking mechanism. A minor design change was made to the locking mechanism of the predicate attachment (K131053) modifying it from connecting to a handpiece with a 560 Flat locking configuration to connecting to a handpiece with a Diamond Flat configuration. To allow for ease of connection/disconnection with the handpiece, a knurl sleeve was added to the proximal end of the proposed OCM-G1 Attachment unlike the predicate (K131053) where the knurl sleeve was located on the handpiece.

The proposed OCM-G1 Attachment remains similar to the predicate attachment (K131053) in terms of operating principles, where it holds and secures a curved burr support sleeve assembly intended for cutting and shaping bone primarily in otology procedures such as cochleostomies. The indications for use, material and manufacturing remain similar to the predicate attachment.

In addition, the OCM-G1 Attachment will utilize the same OCM Curved Burr Support Sleeves as the predicate.

The technological characteristics of the proposed OCM-G1 Attachment are similar to those of the predicate (K131053) device in the following ways:

Both attachments use a patented locking mechanism (input shafts) to secure to . handpiece
Both attachments are compatible with the same OCM curved burr support sleeve 0 assembly currently on the market
. Both attachments by design have a straight outer metal cover with internal components
Both attachments are non-sterile reusable, steam autoclavable devices .

The following technological differences between the proposed and predicate (K131053) device were considered in relation to the substantial equivalence determination:

. Use of a Diamond Flat configuration on the proposed OCM-G1 Attachment for locking mechanism opposed to 560 Flat configuration. The Diamond Flat confiquration allows the proposed OCM-G1 Attachment to be compatible with the G1 handpiece only. The predicate (K131053) is compatible with handpieces compatible with the 560 Flat configuration.
The proposed OCM-G1 Attachment is compatible with an electric powered drill . system while the predicate (K131053) is compatible with various electric and pneumatic powered drill systems. There is no change to the performance of the attachment as compared to the predicate (K131053).
. A knurl sleeve was incorporated on the proximal end of the OCM-G1 Attachment for ease of use and which allows the attachment to be removed from the handpiece

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

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Image /page/6/Picture/21 description: The image shows the word "ANSPACH" in blue, with a registered trademark symbol to the right of the word. To the left of the word is a blue square with a white bird-like figure inside. The text is in a bold, sans-serif font. The overall image has a clean and professional look.

using one less step than the predicate. For the proposed OCM-G1 Attachment, the act of twisting the attachment locks in the dissection tools or burr on handpiece, whereas on the predicate (K131053) retracting (and releasing) the disconnect sleeve allows the dissection tool or burr to be installed/removed.

. Total length of the proposed OCM-G1 Attachment is 2.5mm opposed to 2.6mm of predicate (K131053).
The proposed changes to the OCM-G1 Attachment have no impact on the safety and effectiveness of the device or its ability to perform as intended.

VII. PERFORMANCE DATA

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

Biocompatibility Testing:

The OCM-G1 Attachment does not have direct or indirect patient contact, same as the predicate. A biocompatibility evaluation was conducted for the OCM-G1 Attachment per the FDA quidance document Use of International Standard ISO 10993-1. "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

The OCM-G1 Attachment is manufactured and packaged in the same manner with identical material as the predicate device (K131053). No new or additional processing steps were introduced; therefore, biocompatibility requirements have been met.

Design Control Activities:

The following verification tests were performed to demonstrate that the device meets the performance requirements under its indications for use conditions.

Locking feature compatibility .
Temperature .
Disconnect without tools e
System functionality .

The above tests demonstrate proper functionality, compatibility, safe external temperatures, and the ability to connect and disconnect without the use of tools, the same as the predicate (K131053). A simulated use study demonstrated the OCM-G1 Attachment and curved cutting burrs perform as intended in cutting and shaping bone properly in the same manner as the predicate (K131053).

Cleaning and Reprocessing:

The OCM-G1 Attachment was assessed to determine whether or not current validations for clinical processing and steam sterilization are capable of producing a sterility assurance

Ansnach Comnanie

4500 Riverside Drive, Palm Beach Gardens, Florida 334

Phone (561) 627-1080 · Fax (561) 627-3120 Toll Free Phone (800) 327-6887 · Toll Free Fax (800) 327-6661

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ANSPACH

level (SAL) of 10-6. Overall, the proposed OCM-G1 Attachment device characteristics would be equal or less of a challenge to sterilize than the currently validated "worst case" with the ability to be cleaned and sterilized effectively without adverse effects, same as the predicate (K131053).

Clinical Testing:

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

VII. CONCLUSIONS

The OCM-G1 Attachment described in this submission has the same intended use, general design, material, technological characteristics, and principles of operation as the predicate device (K131053). The introduction of the attachment does not raise any new issues of safety or efficacy and was found to be substantially equivalent to the predicate (K131053) device.

4500 Riverside Drive. Palm Beach Gardens. Florida

Phone (561) 627-1080 · Fax (561) 627 Toll Free Phone (800) 327-6887 · Toll Free Fax (800) 327-6661

Regulation Number and Section

§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.

(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.