(77 days)
Not Found
No
The device description and performance studies focus on mechanical functionality, material properties, and compatibility with existing systems, with no mention of AI or ML.
No.
The device is an accessory to a surgical cutting and shaping system, not a therapeutic device itself. Its purpose is to facilitate a surgical procedure rather than to directly treat a medical condition.
No
The device is described as an accessory to an electric drill system, intended for cutting and shaping bone, which are therapeutic/surgical functions, not diagnostic.
No
The device description clearly states it is a physical attachment made of stainless steel, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and shaping bone primarily in otology procedures such as cocleostomies." This describes a surgical procedure performed directly on a patient's body.
- Device Description: The device is an accessory to an electric drill system used for bone cutting. This is a surgical tool.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform any such tests.
The device is clearly intended for surgical use, not for analyzing biological samples outside of the body.
N/A
Intended Use / Indications for Use
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.
Product codes
ERL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
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
1
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
2
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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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3
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
4
IV. 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.
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 with
Otologic Attachment System (Otologic
Attachment and Curved Burrs) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K180063 | K131053 |
| Indications
for Use | When used with the ANSPACH Systems,
the OCM-G1 Attachment is intended for
cutting and shaping bone primarily in
otology procedures such as
cochleostomies. | When used with the ANSPACH Systems, the
OCM Attachment and OCM Burr Support
Sleeves are intended for cutting and
shaping bone primarily in otology
procedures 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 |
| Locking
Mechanism | 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
5
| 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
7
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