(211 days)
Not Found
No
The device description and performance studies focus on the mechanical properties and compatibility of the dissection tools, with no mention of AI or ML.
Yes.
The device is intended for "cutting and shaping bone including the spine and cranium," which directly relates to treating or alleviating a condition, making it a therapeutic device.
No
Explanation: The device is described as a surgical tool for cutting and shaping bone, not for diagnosing conditions. Its intended use is mechanical intervention rather than information gathering for diagnosis.
No
The device description clearly states that the device is a physical, one-piece metal bone cutting and shaping tool, 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 including the spine and cranium." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details a mechanical tool (burs) used with a drill system for bone manipulation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a patient's health. This device does not perform any such analysis of specimens.
- Anatomical Site: The anatomical site is "bone including the spine and cranium," which are locations within the patient's body where the device is used directly.
The information provided clearly indicates that this is a surgical instrument used for physical manipulation of bone, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.
Product codes (comma separated list FDA assigned to the subject device)
HBE
Device Description
The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system.
The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism.
The Anspach Helix™ Dissection Tools are provided sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone including the spine and cranium.
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The Anspach Helix™ dissection tools are classified as external communicating devices: tissue/bone/dentin with limited patient contact (
§ 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
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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
The Anspach Effort, Inc. Tamara West Regulatory Affairs Manager 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K183545
Trade/Device Name: Anspach Helix Dissection Tools Regulation Number: 21 CFR 882.4310 Regulation Name: Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories Regulatory Class: Class II Product Code: HBE Dated: June 14, 2019 Received: June 17, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Matthew Krueger Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Anspach Helix™ Dissection Tools
Indications for Use (Describe) Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
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
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
Image /page/3/Picture/1 description: The image shows the word "ANSPACH" in large, bold, blue letters. To the left of the word is a blue square with a white bird inside. To the right of the word is a small, superscripted "®" symbol, indicating that the word is a registered trademark. The word is the main focus of the image and is easily readable.
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: June 14, 2019
II. DEVICE
Trade Name: Anspach Helix™ Dissection Tools
Common Name: Dissection Tools
Classification Information: 21 CFR 882.4310 Drills, burs, trephines, and accessories (simple, powered)
Regulatory Class: II
Product Code: HBE
Classification panel: Neurology
III. PREDICATE DEVICE
K113476 Dissection Tools Owner: The Anspach Effort, Inc.
4
Image /page/4/Picture/1 description: The image shows the word "ANSPACH" in large, bold, blue letters. To the left of the word is a blue square containing a white seagull. A small "R" in a circle is located to the upper right of the word.
IV. DEVICE DESCRIPTION
The Anspach Helix™ Dissection Tools (otherwise known as burs) are part of a drill system that consists of a control console, a handpiece (motor), a control switch and various attachments and accessories. The Anspach Helix™ Dissection Tools are onepiece metal bone cutting and shaping devices that attach to the handpiece/attachment of a pneumatic or electric powered drilling system.
The Anspach Helix™ Dissection Tools are manufactured from M2 tool steel and feature a 2-fluted ball sharp cutting edge at the distal end. The proximal end, which secures the dissection tool to the handpiece of the power system, incorporates a patented Diamond Flat configuration locking mechanism.
The Anspach Helix™ Dissection Tools are provided sterile.
V. INDICATIONS FOR USE
Anspach Helix™ Dissection Tools are intended for cutting and shaping bone including the spine and cranium.
| Anspach Helix™ Dissection Tools | Dissection Tools | |
|---|---|---|
| 510(k) Number | K183545 | K113476 |
| Indications for Use | Anspach Helix™ Dissection Tools are used for cutting and shaping bone including the spine and cranium. | Dissection tools are intended for cutting shaping bone including the spine and cranium. |
| Product Code | HBE | HBE |
| Class | 2 | 2 |
| Sterilization | Gamma irradiated | Gamma irradiated |
| Sterilization | ||
| Assurance Level | ||
| (ASL) | 10-6 | 10-6 |
| TECHNOLOGICAL CHARACTERISTICS | ||
| Head Styles | Fluted Ball | Fluted Ball, Fluted Matchstick, |
| Diamond Ball | ||
| Flutes | 2 Flutes | 2 Flutes (Matchstick) |
| 4 – 12 Flutes (Ball) | ||
| Head Diameter | 2mm – 7mm | Fluted Ball: |
| 0.5mm – 9mm | ||
| Material | M2 Tool Steel | M2 Tool Steel, Stainless Steel, |
| Carbide, Diamond coated | ||
| Locking mechanism | Diamond Flat Configuration | Diamond Flat Configuration |
| Labeling | Sterile, single-use | Sterile, single-use |
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33
5
| Packaging
Configuration | PETG tray in a sealed Tyvek pouch
placed into a carton | PETG tray in a sealed Tyvek pouch |
|----------------------------|-----------------------------------------------------------|-----------------------------------|
| Shelf life | 5 years | 5 years |
The predicate dissection tools (K113476) are part of an electric/pneumatic drill system and are available in many different styles and dimensions, including a fluted ball. A minor design modification was made to the head of the existing fluted ball style by offering a 2fluted style as compared to 4 or more flutes with the predicate device. The 2-fluted style was developed to provide a dissection tool that produces less chatter and vibration while cutting than the predicate dissection tools (K113476).
The proposed Anspach Helix™ Dissection Tools remain identical to the predicate dissection tools (K113476) in terms of operating principles, where it attaches to the handpiece/attachment of either an electric or pneumatic drill utilizing the diamond flat locking mechanism. The indications for use, material and manufacturing remain identical to the predicate dissection tools (K113476).
The technological characteristics of the proposed Anspach Helix™ dissection tools are similar to those of the predicate (K113476) device in the following ways:
- Both dissection tools use a patented locking mechanism on the distal end to secure to the handpiece
- · Both dissection tools are compatible with the same electric and pneumatic drill systems, including attachments
- Both dissection tools have a straight shaft and fluted ball style head, where the proposed dissection tools have 2 flutes opposed to 4 or more flutes of the predicate dissection tools
- · Both dissection tools are provided sterile
As with the predicate dissection tools (K113476), the Anspach Helix™ Dissection Tools have no impact on the safety and effectiveness of the device or the ability to perform as intended.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility Testing:
The Anspach Helix™ dissection tools are classified as external communicating devices: tissue/bone/dentin with limited patient contact ( Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33410
6
Image /page/6/Picture/1 description: The image shows the word "ANSPACH" in large, bold, blue letters. To the left of the word is a blue square containing a white bird in flight. A small circled "R" symbol is located in the upper right corner of the word.
evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The Anspach Helix™ Dissection Tools are manufactured and packaged in the same manner with identical material as the predicate device (K113476). No new or additional processing steps were introduced; therefore, biocompatibility requirements have been met.
Design Control:
The following verification activities were performed to demonstrate that the device meets the performance requirements under its indications for use conditions for determination of substantial equivalence.
| Test | Test Method Summary | Results |
|---|---|---|
| Verification Analysis - Mating | ||
| Clearance & Anti-Rotation | ||
| Interference | Conduct a tolerance analysis to | |
| determine that there is mating | ||
| clearance and anti-rotation | ||
| interference when engaged with | ||
| drive spindle of EG1, XMAX, & | ||
| EMAX2PLUS handpieces | The analysis shows that the | |
| design output meets the design | ||
| input; the proposed Helix | ||
| dissection tools drive feature | ||
| meets the acceptance criteria of | ||
| mating clearance and anti- | ||
| rotation interference when | ||
| engaged with drive spindles of | ||
| EG1, XMAX, & EMAX2PLUS | ||
| handpieces. | ||
| Helix Dissection Tool and | ||
| Attachment Compatibility - Shaft | ||
| Diameter/Shaft Length | Conduct a tolerance analysis to | |
| determine the minimum and | ||
| maximum clearance between the | ||
| shaft diameter of the dissection | ||
| tool and inner race bearing | ||
| diameter of the attachment. | Analysis was performed by | |
| evaluating all Helix dissection | ||
| tools and attachment (predicate) | ||
| combinations to confirm | ||
| compatibility. | ||
| Tolerance analysis reflects 0.0001 | ||
| to 0.0007 inches of clearance | ||
| between dissection tools and the | ||
| attachment which is in the | ||
| required range of scope with a | ||
| 3/32-inch shaft diameter and the | ||
| inner race bearing diameter of | ||
| compatible attachments as listed | ||
| in the compatibility table. | ||
| Tolerance analysis reflects that | ||
| the minimum length in the lock | ||
| position exists, so the head will | ||
| not interfere with the attachment. | ||
| Tolerance analysis reflects that | ||
| the tapered section of the | ||
| dissection tool will not interfere | ||
| with the distal bearing inner | ||
| diameter of the attachment. |
Anspach Companies 4500 Riverside Drive, Palm Beach Gardens, Florida 33410
7
| Helix Ball Bur Chatter/Cut and
| Shape Verification Report | ||
|---|---|---|
| The % chatter for each group of | ||
| same-size Helix ball burs must | ||
| be less than the chatter of the | ||
| corresponding group of same- | ||
| size predicate G1 | ||
| burs, as determined by a | ||
| hypothesis test with a | ||
| significance level (alpha) = 0.10. | All samples met the acceptance | |
| criteria and exhibited statistically | ||
| lower% chatter than the | ||
| corresponding same size | ||
| predicate devices with the | ||
| exception of the S-25SB-HX-G1-1. | ||
| For this size, while lower, the | ||
| results were not statistically | ||
| significant as compared to the | ||
| corresponding same size | ||
| predicate. | ||
| Each Helix ball bur used to cut | ||
| into the Bi-resin (simulated | ||
| bone) samples and then shall be | ||
| evaluated to confirm that they | ||
| cut and shape bone the same as | ||
| the predicate. | All samples met the acceptance | |
| criteria to cut and shape bone, | ||
| the same as the predicate. | ||
| Each Helix ball bur used to cut | ||
| into the Bi-resin (simulated | ||
| bone) samples and then shall be | ||
| visually inspected for cutter head | ||
| fracture with the acceptance | ||
| criteria of the bur head intact on | ||
| the cutter and not broken, the | ||
| same as the predicate. | All samples met the acceptance | |
| criteria for the head of the cutter | ||
| to remain intact, the same as | ||
| the predicate. |
The above verification activities demonstrate the Anspach Helix™ Dissection Tools perform as intended in cutting and shaping bone in the same manner as the predicate (K113476) and are compatible with existing predicate devices (K113746). Verification activities also demonstrate that select Helix designs exhibited statistically significantly lower chatter and vibration while cutting than the corresponding same size burs of the predicate devices (K113476). Based on the results of the verification activities, the proposed Anspach Helix™ Dissection Tools are determined to be substantially equivalent to the predicate devices (K113476).
No animal or clinical testing was necessary for a determination of substantial equivalence.
VII. CONCLUSIONS
The Anspach Helix™ Dissection Tools described in this submission have the same intended use, general design, material, technological characteristics, and principles of operation as the predicate device (K113476) and do not raise any new issues of safety or efficacy. In addition, the select 2-flute designs that are part of the marketing claims within this submission also do not raise any new issues of safety or efficacy and were found to be substantially equivalent to the predicate devices (K113476). Therefore, the proposed Anspach Helix™ Dissection Tools are found to be substantially equivalent to the predicate devices.