(259 days)
Not Found
No
The device description focuses on mechanical components and performance characteristics of surgical drills and attachments, with no mention of AI or ML capabilities.
No
The device is a surgical drill and attachments intended for cutting and shaping bone, which is an interventional procedure, not a therapeutic one.
No
The device is described as surgical drills and burrs intended for cutting and shaping bone, which are therapeutic actions, not diagnostic.
No
The device description clearly outlines physical hardware components: surgical drills, attachments, and burr support sleeves. There is no mention of software as the primary or sole component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The ANSPACH® Systems and OCM Attachment/Burr Support Sleeves are surgical tools used for cutting and shaping bone during surgical procedures performed on the patient's body. They are used directly on the patient's tissue.
- Intended Use: The intended use clearly states "cutting and shaping bone including spine and cranium" and "cutting and shaping bone primarily in otology procedures." This describes a surgical intervention, not a diagnostic test performed on a sample.
The device description and performance studies further reinforce that this is a surgical instrument, focusing on its mechanical function, safety during use on the patient, and sterilization. There is no mention of analyzing biological samples.
N/A
Intended Use / Indications for Use
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium.
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.
Product codes (comma separated list FDA assigned to the subject device)
ERL, EQJ
Device Description
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection.
The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert.
The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20deg curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone including spine and cranium, otology procedures such as cochleostomies.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of biocompatibility tests demonstrated the safety of the OCM Burr Support Sleeves patient contacting materials. All tests were conducted in accordance with the GLP regulation (21 CFR Part 58).
Several performance tests demonstrated the safety and effectiveness of the OCM Attachment and OCM Burr Support Sleeves. Specifically, OCM Attachment testing demonstrated proper functionality after repeated use, safe external temperatures, and the ability to clean and sterilize effectively without adverse effects on functionality or performance. OCM Burr Support Sleeves testing demonstrated proper functionality and safe external temperatures. In addition, a simulated use study demonstrated both the OCM Attachment and the OCM Burr Support Sleeves perform as intended in cutting and shaping bone properly.
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
§ 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
DEC 3 1 2013
510(k) PREMARKET NOTIFICATION ANSPACH® Systems with Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves
510(k) Summary
| Submitter
Information | Company: | The Anspach Effort, Inc.
4500 Riverside Drive
Palm Beach Gardens, FL 33410 |
|---------------------------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jeannette G. Dailey
Regulatory Affairs Manager |
| | Email: | Dailey.Jeannette@synthes.com |
| | Telephone: | 561-494-3710 |
| | FAX: | 561-625-9110 |
| | Date Prepared: | November 8, 2013 |
| Identification of
the Device | Common Names: | Pneumatic and Electric Surgical Instruments
and Attachments |
| | Device Name: | ANSPACH® XMax Pneumatic and eMax 2 and
eMax2 Plus Electric Systems with the
ANSPACH® Otologic Curved Micro (OCM)
Attachment and OCM Burr Support Sleeves |
| | Classification Names: | • Ear, nose and throat electric or pneumatic
surgical drill
• Ear, nose and throat bur |
| | Device Classification: | • Class II, 21 CFR 874.5250 (drill)
• Class 1, 510(k) exempt, 21 CFR 874.4140 (bur) |
Predicate Devices(s) The subject devices are substantially equivalent to the following predicate devices:
The electric and pneumatic surgical drills are identical to the currently marketed electric and pneumatic surgical drills:
- ANSPACH® XMax Pneumatic System cleared via K965080 .
- ANSPACH® eMax 2 and eMax2 Plus Electric Systems cleared via . K011444
The Otologic Curved Micro (OCM) Attachment and OCM Burr Support Sleeves are substantially equivalent to the handpiece and burrs associated with the:
- . Medtronic. Inc., XPS® 3000 System cleared most recently via K073255 on March 24, 2008
Continued on next page
1
510(k) Summary, Continued
| Description of Device | The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are surgical drills that handle a complete range of surgical procedures ranging from power demanding applications to the most delicate dissection. |
|---|---|
| The ANSPACH® Otologic Curved Micro (OCM) Attachment consists of the attachment which connects directly to the ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems handpieces with the standard twist lock mechanism, and the OCM Burr Support Sleeves. The OCM is provided non-sterile and is reusable. Cleaning and sterilization instructions are provided in the ANSPACH® OCM Attachment package insert. | |
| The ANSPACH® OCM Burr Support Sleeves with integral cutting burrs mount to the OCM Attachment with a simple snap-in connection. The 20° curve and small diameter of the OCM Burr Support Sleeves provides excellent visibility. The non-rotating support sleeve protects soft tissue from the rotating cutting burr shaft. The OCM Burr Support Sleeves can be used at speeds from 10,000 to 80,000 rpm. They are available in two lengths (5.6 and 7.3 cm), each with a wide variety of different cutting burr styles and diameters to accommodate varying surgeon preferences. The OCM Burr Support Sleeves are provided sterile and for single use only. | |
| Indications for Use | The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electric Systems are intended for cutting and shaping bone including spine and cranium. |
| 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. |
Continued on next page
.
.
2
510(k) Summary, Continued
| Technological
Characteristics | There are no new technological characteristics associated with the
ANSPACH® Pneumatic and Electric Systems, the OCM Attachment
and the OCM Burr Support Sleeves. The ANSPACH® XMax
Pneumatic and eMax 2 and eMax2 Plus Electric Surgical Drills are
identical to the currently marketed electric and pneumatic surgical drills.
The new ANSPACH® Otologic Curved Micro (OCM) Attachment and
OCM Burr Support Sleeves utilize the same biocompatible materials as
currently marketed attachments and burrs. The packaging,
manufacturing method, and cleaning and sterilization methods of the
OCM Attachment are the same as currently marketed ANSPACH® |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | attachments. The OCM Burr Support Sleeves packaging,
manufacturing method and sterilization method are also the same as
currently marketed ANSPACH® burrs.
The new indications for use are consistent with numerous other
currently marketed surgical drill systems and accessories. |
| Non-Clinical
Testing | A series of biocompatibility tests demonstrated the safety of the OCM
Burr Support Sleeves patient contacting materials. All tests were
conducted in accordance with the GLP regulation (21 CFR Part 58).
Several performance tests demonstrated the safety and effectiveness of
the OCM Attachment and OCM Burr Support Sleeves. Specifically,
OCM Attachment testing demonstrated proper functionality after
repeated use, safe external temperatures, and the ability to clean and
sterilize effectively without adverse effects on functionality or
performance. OCM Burr Support Sleeves testing demonstrated proper
functionality and safe external temperatures. In addition, a simulated
use study demonstrated both the OCM Attachment and the OCM Burr
Support Sleeves perform as intended in cutting and shaping bone
properly. |
| Conclusions | Scientifically valid data demonstrates that the ANSPACH® XMax
Pneumatic and eMax 2 and eMax2 Plus Electric Systems with the
ANSPACH® Otologic Curved Micro (OCM) Attachment and OCM Burr
Support Sleeves is as safe and effective as the predicate devices when
used in accordance with the labeled directions for use and for the
requested indication. |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
December 31, 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
The ANSPACH Effort, Inc. % Ms. Annette M. Hillring 3012 St. Charles Drive Tampa, FL 33618
Re: K131053
Trade/Device Name: ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Electrical Systems with Otologic Attachment System (Otologic Attachment and Curved Burrs) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose and Throat Electric or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL; EQJ Dated: November 26, 2013 Received: December 2, 2013
Dear Ms. Hillring:
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,
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.
4
Page 2 - Ms. Annette M. Hillring
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
Bradley S. Cunningham -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
5
Indications for Use
510(k) Number (if known): K131053
Device Name: ANSPACH® XMax Pneumatic and eMax2 and eMax2 Plus Electrical Systems with Otologic Attachment System
The ANSPACH® XMax Pneumatic and eMax 2 and eMax2 Plus Indications for Use: Electric Systems are intended for cutting and shaping bone including spine and cranium.
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.
Prescription Use V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sageev George -S 2013.12.27 17:13:53 -05'00'
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