(24 days)
Not Found
No
The document describes a mechanical surgical tool and a change to its locking mechanism. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is a cutting tool for bone, which is used in surgical procedures and does not involve therapeutic action or treatment of a disease.
No
Explanation: The device is described as a "cutting device" for "surgical bone cutting and shaping procedures." It is used for therapeutic purposes (dissection and shaping bone), not for diagnosis.
No
The device description clearly states that the device is a physical cutting tool made of materials like tool steel, stainless steel, or carbide, designed for surgical bone cutting and shaping. It is a hardware component used with motor systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "cutting and shaping bone including spine and cranium." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as "actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems" for "surgical bone cutting and shaping procedures." This further reinforces its use in a surgical setting.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a patient's health. IVDs are specifically designed for this type of testing.
Therefore, the Anspach Dissection Tools are surgical instruments, not in vitro diagnostic devices.
N/A
Intended Use / Indications for Use
Dissection tools are intended for cutting and shaping bone including spine and cranium.
Product codes (comma separated list FDA assigned to the subject device)
HBE
Device Description
The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems. The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system. Dissection Tools are sterilized, individually packaged, are for single use and disposable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine and cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical/surgical personnel
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools. These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards. Based on the testing, risk analysis and comparison to the predicate devices, the Dissection Tools described in this submission perform as intended and raises no new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools
DEC 1 6 2011
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 |
| ----------- | ---------------------------------------------------------------------------------- |
|---|
- Official Correspondent Jeannette G. Dailey Regulatory Affairs Manager Tel. 561-494-3710 Fax. 561-625-9110 Email dailey.jeannette@synthes.com
Class II
Dissection Tools
(Compound Powered)
Date Prepared December 13, 2011
Device Name
..............................................................................................................................................................................
Classification Name
Device Classification
Predicate Devices
Neurological Devices Panel 21 CFR §882.4310 HBE
Drills, Burrs, Trephines & Accessories
eMax2 Plus System (Component to system) K080802
Minimal Access Spinal Attachment (MASA) System (Component to system) K042783
Device Description
The Anspach Dissection Tools are the actual cutting devices designed exclusively for use with Anspach pneumatic or electric motor systems. These Dissection Tools are designed for surgical bone cutting and shaping procedures by trained medical/surgical personnel. Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors and attachments with which they will be used. The
1
The Anspach Effort, Inc. Special 510(k) Premarket Notification - Dissection Tools
base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips. Dissection Tools are components to existing Anspach electric and pneumatic systems.
The purpose of this submission is to describe a new design of the locking mechanism of the Dissection Tools. The locking mechanism provides a means to secure a Dissection Tool to the handpiece of the power system.
Indications for Use Dissection tools are intended for cutting and shaping bone including spine and cranium.
Dissection Tools are sterilized, individually packaged, are for single use and disposable.
Dissection Tools have a standard attachment mechanism, designed specifically for the type(s) of motors both electric and pneumatic, and attachments with which they will be used. The base materials of the Dissection Tools are tool steel, stainless steel, or carbide construction with some containing a coated layer of diamond chips.
Performance Testing
Technological
Characteristics
Design verification was conducted on the proposed design change of the locking mechanism of the Dissection Tools.
These tests include a functional approach that challenged the design output against the design requirements. The tests verified established physical characteristics, functional requirements and performance standards.
Conclusion
Based on the testing, risk analysis and comparison to the predicate devices, the Dissection Tools described in this submission perform as intended and raises no new safety or effectiveness issues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
The Anspach Effort, Inc. c/o Ms. Jeanette G. Dailey Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, FL 33410
DEC 1 6 2011
Re: K113476
Trade/Device Name: Dissection Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, bores, trephines, and their accessories Regulatory Class: Class II Product Code: HBE Dated: November 18, 2011 Received: November 22, 2011
Dear Ms. Dailey:
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. Ilsting 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.
3
Page 2 - Ms. Jeanette G. Dailey
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 (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Malvina B. Eydelman, M.D.
Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): __K113476
Device Name:_Dissection Tools
Indications For Use:
Dissection tools are intended for cutting and shaping bone including spine and cranium.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
1000
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
JOE HUTTER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
Page 1 of
K113476 510(k) Number _