(72 days)
Not Found
Not Found
No
The device description focuses on mechanical components and their function in surgical bone dissection, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is used for surgical cutting, shaping, and removal of bone, which indicates a surgical tool rather than a therapeutic device designed to treat a disease or condition.
No
Explanation: The device is described as a surgical attachment system used for cutting, shaping, and removal of bones during surgery. Its function is interventional/therapeutic, not diagnostic.
No
The device description clearly outlines physical components (Angled Motor Adaptor, Nose-tube/bearing housings, cutters) and their materials, cleaning, and sterilization processes, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical cutting, shaping and removal of bones, including bones of the spine and cranium." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device components are mechanical tools (motor adaptor, nose-tube, cutters) used for physical manipulation of bone tissue.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or provide diagnostic information about a patient's condition. IVD devices are used in vitro (outside the body) to diagnose diseases or conditions.
This device is clearly a surgical instrument used in vivo (within the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.
Product codes (comma separated list FDA assigned to the subject device)
HBE
Device Description
The Minimal Access Spinal Attachment system consists of three basic components: Angled Motor Adaptor (20° Driver Body); Nose-tube/bearing housings; and a vanety of bone dissection tools (cutters").
Angled Motor Adaptor (20° Driver Body): Two designs, one for the Black Max motor and one for MicroMax/XMax and eMax Motors.
The 20° Driver Body is a non-invasive and non-patient contact component of the Minimal Access Spinal Attachment system that connects to the surgical motor. Unlike other attachments, the Minimal Access Spinal Attachment is designed to provide a 3.0mm length adiustment of the nose-tube/bearing sleeves.
The 20° Driver Body is reusable, distributed clean and nonsterile. It is designed to be cleaned with (non-immersion) soapy-water and/or full immersion in isopropyl alcohol. Recommended cleaning and sterilization processes are provided with each device.
Nose tube/bearing sleeves: Four initial tube designs*
-
- Long Curved (10+/- 2°)
-
- Long Straight
-
- Short Curved (10+/- 2°)
-
- Short Straight
- Additional lengths to become available
The nose-tube/bearing sleeve is reusable, provided it is properly handled, cleaned, and maintained as directions for use (DFU), provided with each product. When increased bearing wear is observed (increased heat and/or noise), the bearing tube is removed from the Driver Body and discarded. A replacement nose-tube is then simply inserted and locked onto the Driver. Like the 20° Driver, nose-tuberbearing sleeves can be steam autoclaved before use in accordance with DFU.
Cutters (Bone Dissection Tools):
Minimal Access Spinal Attachment system cutters are the variety of pre-sterlized, single-use, disposable bone dissection tools. Minimal Access Spinal Attachment cutters are individually packaged and distributed pre-stenlized. A variety of cutting tip designs and diameters in lengths to fit all Nose tube/bearing housings are available with additional sizes and head configurations available in the future.
Cutters are of the same basic design and materials as other currently distributed cutters and are individual packaged and pre-sterilized. Terminal sterilization is achieved by Irradiation to a sterility assurance level (SAL) of 10. User assembly instructions are provided with each component of the system and also in a variety of catalogs and surgical manuals.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones of the spine and cranium
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Anspach manufactured equipment is contraindicated for surgical use by anyone not qualified through education and experience, in proper use of Anspach product.
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)
Risk assessment has been accomplished for the Minimal Access Spinal Attachment system. All identified risks and hazards associated with design, production, performance and use of the Minimal Access Spinal Attachment system were capable of being reduced to acceptable levels through design, process and/or labeling activities.
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).
0
Specialty Attachment 510(k) SUMMARY: -Minimal Access Spinal Attachment system
KO4 2783 CLASSIFICATION: US Class II
PERFORMANCE STANDARDS:
No known performance standards.
DESIGN, MATERIALS AND OPERATION CHARACTERISTICS:
The Minimal Access Spinal Attachment system consists of three basic components: Angled Motor Adaptor (20° Driver Body); Nose-tube/bearing housings; and a vanety of bone dissection tools (cutters").
Angled Motor Adaptor (20° Driver Body): Two designs, one for the Black Max motor and one for MicroMax/XMax and eMax Motors.
The 20° Driver Body is a non-invasive and non-patient contact component of the Minimal Access Spinal Attachment system that connects to the surgical motor. Unlike other attachments, the Minimal Access Spinal Attachment is designed to provide a 3.0mm length adiustment of the nose-tube/bearing sleeves.
The 20° Driver Body is reusable, distributed clean and nonsterile. It is designed to be cleaned with (non-immersion) soapy-water and/or full immersion in isopropyl alcohol. Recommended cleaning and sterilization processes are provided with each device.
Nose tube/bearing sleeves: Four initial tube designs*
-
- Long Curved (10+/- 2°)
-
- Long Straight
-
- Short Curved (10+/- 2°)
-
- Short Straight
- Additional lengths to become available
The nose-tube/bearing sleeve is reusable, provided it is properly handled, cleaned, and maintained as directions for use (DFU), provided with each product. When increased bearing wear is observed (increased heat and/or noise), the bearing tube is removed from the Driver Body and discarded. A replacement nose-tube is then simply inserted and locked onto the Driver. Like the 20° Driver, nose-tuberbearing sleeves can be steam autoclaved before use in accordance with DFU.
Cutters (Bone Dissection Tools):
Minimal Access Spinal Attachment system cutters are the variety of pre-sterlized, single-use, disposable bone dissection tools. Minimal Access Spinal Attachment cutters are individually packaged and distributed pre-stenlized. A variety of cutting tip designs and diameters in
1
lengths to fit all Nose tube/bearing housings are available with additional sizes and head configurations available in the future.
Cutters are of the same basic design and materials as other currently distributed cutters and are individual packaged and pre-sterilized. Terminal sterilization is achieved by Irradiation to a are interility assurance level (SAL) of 10 . User assembly instructions are provided with each component of the system and also in a variety of catalogs and surgical manuals.
RISK ASSESSMENT:
Risk assessment has been accomplished for the Minimal Access Spinal Attachment system. All identified risks and hazards associated with design, production, performance and use of the Minimal Access Spinal Attachment system were capable of being reduced to acceptable levels through design, process and/or labeling activities.
INDICATIONS / CONTRAINDICATIONS:
The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.
Anspach manufactured equipment is contraindicated for surgical use by anyone not qualified through education and experience, in proper use of Anspach product.
CLEANING/STERILIZATION/MAINTENANCE:
Cleaning, sterilization and maintenance instructions are provided in product use manuals available to all purchasers and Instructions (directions) For Use (IFU/DFU) that accompany each product. Unauthorized repairs and maintenance can be grounds for termination of warranty benefits.
WARNINGS and CAUTIONS:
Generic Warnings for use of Anspach products are specified in manuals and on product inserts. For safe and effective use of any Anspach product, specialized training is required as surgical techniques are highly specialized procedures. Improper surgical technique or improper use of product can cause injury or death to a user or patient and damage to product.
SUBSTANTIAL EQUIVALENCE:
The Minimal Access Spinal Attachment system is substantially equivalent to the Anspach Angled Micro-nose Attachment and the Medtronic (Midas Rex) "Micro-Telescoping System". See attached comparison chart on the following page:
2
| | Anspach
Minimal Access | Anspach
MICRO/MDA | Midas*
Rex |
|---------------------------------|---------------------------|----------------------|---------------|
| Use w/Electric motor1 | Y | Y | Y |
| Use w/Pneumatic motor1 | Y | Y | Y |
| Tool-Less attachment | Y | Y | Y |
| 20° angled driver | Y | Y | N |
| Length adjustable | Y | N | Y |
| Nose tube diameters | 4-5mm (taper) | 3-4mm | 5.0mm |
| Nose tube lengths | 7-30cm | 16cm | 8-15cm |
| Curved nose tube radius | 10+/- 2° | N | 10° 2 |
| Cutter shaft diameter | 1.4mm | 1.43mm | 1.4mm |
| Operating temperature(Max) | 120° | 120° | 120°2 |
| Stainless steel construction | Y | Y | Y |
| Corrosion resistant bearings | Y | Y | ? |
| Immersion cleaning | Y3 | N | N |
| 4 Min flash sterilization** | Y | Y | Y |
| Sterrad sterilization | Y | Y | ? |
| Pre-sterilized cutters (SAL106) | Y | Y | Y |
| Service/Repair (20° Driver) | Y | Y | ?2 |
| Service/Repair (Nose-tubes) | N4 | Y | ?2 |
| Service/Repair (Cutters) | N | N | ?2 |
- Medtronic, Midas Rex "Legend"™ Micro-Telescoping System
** Flash sterilization is only recommended for immediate use in the operating theater.
1 Anspach product compatible with Anspach product only.
- 2 Information provided should be considered average or unknown (?), as it is unknown what level of design, production or performance controls are established for specific devices.
- 3 Nose tubes may be fully immersed. 20° Driver is designed for full immersion in Isopropyl alcohol during cleaning processes for sterilization and reuse, but continues to be labeled "Do not Immerse" to prevent immersion in saline or other fluids while in the surgical theater.
- 4 Nose-tubes are designed for reuse until bearing wear (heat/noise) becomes noticeable, at which time nose-tubes should be disposed of.
End Summary
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Mr. William G. Conety Director, Regulatory Affairs and Ouality Assurance The Anspach Effort 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K042783
Trade/Device Name: Minimal Access Spinal Attachment System Regulation Number: 21 CFR 882.4310 Regulation Name: Powered simple cranial drills, burrs, trephines, and their accessories Regulatory Class: II Product Code: HBE Dated: December 8, 2004 Received: December 10, 2004
Dear Mr. Conety:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rovewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrease, 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.
4
Page 2 - Mr. William G. Conety
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number: K (542783
Page 1 of 1
Device Name: Minimal Access Spinal Attachment system
INDICATIONS FOR USE:
The Anspach Minimal Access Spinal Attachment system is indicated for use as a nosepiece attachment with Anspach pneumatic and electric surgical drill systems for surgical cutting, shaping and removal of bones, including bones of the spine and cranium.
Prescription Use: _ × (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 IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_ K04 2783