(27 days)
Not Found
Not Found
No
The device description and intended use clearly describe a mechanical coupling device with no mention of software, data processing, or AI/ML terms.
No
The device is an interface coupling device designed to attach a surgical drill to a bone mill. It does not perform any therapeutic function itself, but rather facilitates the operation of another device (bone mill) which is used in a surgical procedure.
No.
The device is described as an "interface coupling device" for surgical equipment (bone mills) and does not mention any function related to diagnosing medical conditions.
No
The device description explicitly states it is a "simple attachment; comprised of a cylindrical housing with external locking feature" and describes physical attachment mechanisms, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect a surgical drill to a bone mill for surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically involving testing of samples like blood or tissue).
- Device Description: The device is a mechanical coupler designed to physically connect two surgical instruments. It does not involve any testing of biological samples or diagnostic procedures.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for use by trained medical personnel as an interface coupling device, to permit attachment to and operation of the Medtronic, Midas Rex "Legend" (BM1100) and Disposable Bone Mill (BM200) with an Anspach motor.
Product codes (comma separated list FDA assigned to the subject device)
II
Device Description
The Coupler is a simple attachment; comprised of a cylindrical housing with external locking feature, that when inserted, fits the bone mill. The coupler is designed to attach and lock onto the Anspach spindle (drive shaft).
There are two coupler designs; one for Black Max and one for Micro/Max/xMax and eMax.
Attachment is a simple insertion/twist motion, to align cantilever tabs with the Bone Mill "D-lock" mechanism. Attachment is a simple insertion/twist motion that depresses the two coupler cantilever tabs, unlocking coupler from the bone mill for easy removal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical 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)
Not Found
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.
Not Found
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).
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2005 APR 7
Page 13 of 14
Page 1 of 2
Exhibit 16-01
510(k) SUMMARY: -
CLASSIFICATION NAME: Powered simple cranial drills, burrs trephines and their accessories
COMMON/USUAL NAMES: Nosepiece attachment; nose-tube; Coupler, Adaptor, etc.
CLASSIFICATION: US Class II / EU Class IIa
APPLIED (PERFORMANCE) STANDARDS:
There are no known standards established for powered, simple cranial drills, burrs, trephines, There are no known standards established for powerou, standards for bone mills of
and their accessories at this time. There are no known performal accepted standards for and their accessories at this tiffe. There aile no knowledge and accepted standards for
adaptors for powering devices for bone mills. Appropriate international accepted and adaptors for powering devices for bone mills. " Repreprise in Systems are applied.
SUMMARY:
The Coupler is a simple attachment; comprised of a cylindrical housing with external locking The Coupler is a simple attachment, complised or a vysically locks the coupler to the bone mill. The bone mill. The bone mill. The bone mill. The bone mill. feature, that when Inserted fints the bone mint the Anspach drive shaft, to permit
coupler is designed to attach and lock onto the Anspack (dive shaft) coupler is designed to attach and 100x spindle (drive shaft).
There are two coupler designs; one for Black Max and one for Micro/Max/xMax and eMax.
Attachment is a simple insertion/twist motion, to align cantilever tabs with the Bone Mill "D-lock" Attachment is a simple insertion.wist motion that depresses the two coupler cantilever tabs, unlocking coupler from the bone mil for easy removal.
IDENTIFIED ADDITIONAL RISKS:
Locking tab damage or excessive/premature wear:
Appropriate design considerations (materials, design, etc.) for such wear are incorporated and Approphate design ochelabrations (includermined design requirements.
Bone mill design change to inhibit use of the Anspach motor/coupler assembly:
Thought possible, it would be highly unlikely as it would require a similar design revision to all Thought poosibled Midas Rex Motors and/or bone mills.
INDICATIONS / CONTRAINDICATIONS:
The Anspach Surgical Drill, Specialty Nosepiece Attachment "Adaptor/Coupler" is indicated for The Anspach Surgical Dill, Specially Nosepted Italy, Novice, to permit attachment to and use by trained medical personnel as an intentional Mill (BM1100) and Disposable Bowl
operation of the Medtronic, Midas Rex "Legend" (1934) and Disposable Bowl operation of the Medifonic, Midas Rex "Esgeria "Dono Mill (Entrol)
(BM200) with an Anspach motor. It is contraindicated for use by untrained personnel or as a (DMZOO) with an ment for any other competitive device.
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Page 14 of 14
Page 2 of 2
CLEANING/STERILIZATION/MAINTENANCE:
The Anspach Coupler is distributed clean, non-sterilized and is intended to be a re-usable The Anspach Coupler is distinuted to be subjected to gross bio-contact and with soiled gloves could cause external bio-contamination. Valiated cleaning, disinfection,
with soiled gloves could cause external bio-contaminations are crowind use manuals with soiled gloves could cause extential pro-condininations are provided in product use manuals
sterilization, and routine maintenance recommendations are lee JIEUN that acco sterilization, and routine maintenance recommendations are provide in that accompany in each product.
The Anspach Coupler is not serviceable by user or third parties but remains fully serviceable The Anspach Coupler is not service/repair activities can invalidate warranty.
WARNINGS and CAUTIONS:
Generic Wamings and Cautions for use of Anspach motor systems, attachments and cutters Generic Warnings and Cautons in use of Anser and effective use of any Anspach product, it is are specified on product insents. For sale and enconvers since surgical techniques using
strongly suggested that specialized training be undertaken since surgical technique strongly suggested that specialized training bookures. Improper surgical technique
Anspach products are highly specialized and complex procedures. Improper surging and Anspach products are highly specialized and common proceath to a user or patient and or improper use of Anspach products and/or other equipment.
SUBSTANTIAL EQUIVALENCE:
The Anspach coupler is substantially equivalent to other Anspach Attachments in that it is The Anspach coupler is substantially equivaline to other may has and support a bone cutting/ processing device (cutter, saw, perforator, chuck system, etc.).
| | Anspach
Coupler | Other Anspach
Nosepiece Attachments |
|-----------------------------------|--------------------|----------------------------------------|
| Use w/Pneumatic & Electric motors | Y | Y |
| Tool-Less attachment | Y | Y |
| For use with Competitor Device(s) | Y | - |
| Straight Nosepieces: | | N |
| Saggital Saw: | | Y |
| Chuck System: | | Y |
| Speed Reducers: | | Y |
| Input Speed | 80-85k | 80-85k |
| Operating temperature (Max) | 120° Max | 120° Max |
| Stainless steel construction | Y | Y |
| Corrosion resistant bearings | Y | Y |
| Immersion cleaning | Y | Y |
| Steam Sterilization | Y | Y |
| Sterrad sterilization | Y | Y |
| User Service/Repair | N | N |
| Anspach Service/Repair | Y | Y |
| | End Summary | |
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 consists of a stylized caduceus, which is a symbol of medicine, with three horizontal bars representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Public Health Service
2009 APR 7
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. William G. Conety IMI: William O: Sollow,
Director, Regulatory Affairs and Quality Assurance Anspach Companies 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K050628
Trade/Device Name: Adaptor/ Coupler Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: HBE Product Code: II Dated: March 7, 2005 Received: March 11, 2005
Dear Mr. Conety:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave decembined the acress to recess to vices marketed in interstate for use stated in the encrosule) to regally mancted provice Americal Device Ameralments, or to commerce prior to May 28, 1970, the enactified in accordance with the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the PMAN devices that have been reclassified in accordance was a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval ions and Cosment Act (Act) that do not require approval controls provisions of the Act. The You may, therefore, market the device, secject to the girls annual registration, listing of
general controls provisions of the Act include requirements for and general controls provisions of the Fiel networks of the same of the misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) into e. Existing major regulations affecting your device . EDA if may be subject to such additional concreter - Einemage 21, Parts 800 to 898. In addition, FDA can be lound in the Code of I cuefar Regulations, Ferran Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualier of a successful other requirements of the Act
that FDA has made a determination that your device complies with on any that FDA has made a decemination that Jour seee a agencies. You must or any Federal statutes and regulations daminders as of not limited to: registration and listing (21 let comply with all the Act s requirements, mercessed manufacturing practice requirements as set CFR Part 807), labeling (21 CFR Part 800), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QD) regalations (Sections 531-542 of the Act); 21 CFR 1000-1050.
Product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2 – Mr. William G. Conety
This letter will allow you to begin marketing your device as described in your Section 510(k)
The same of the same of a line of a list as the tisk assivelence of your device This letter will allow you to begin maketing your advice of your device of your device to a legally
premarket notification. The FDA finding of substantial equivales of fyour premarket notification. The FDA miding of Substantal organ and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the regulation of 1010 - 1010 - Also, also - Also, plass note the regula If you desire specific advice for your de vice on our an accesses not the regulation entitled, the regulation entitled, the contact the Office of Compliance at (240) 270 - 1200) Part 807.97). You may obtain
"Misbranding by reference to premarket notification" (21) - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 "Misbranding by reference to premarkst nonlied.com (1) it it from the Division of Small
other general information on your responsibilities under the Act from wwbar (800) 638other general information on your responsibility in the 2014 fires number (800) 638-2041 or
Manufacturers, International and Consumer Assistance at iss toll-free number (800) Manufacturers, International and Consulter Assistance arovedrh/industry/support/index.html.
Sincerely yours,
E.O.T.
Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4