(40 days)
The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.
The eMax 2 Plus System is an electrically powered drill motor with a series of attachments designed for use on the bones of the cranium and spine. The system components include a control console, the motor hand piece and foot control switch. The control console supplies power to the motor through a detachable cable. This system is non-sterile.
The provided text is a 510(k) summary for the eMax 2 Plus System, which is an electrically powered drill motor designed for cutting and shaping bone in cranium and spine. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical performance study for an AI/CADe device would.
Instead, this 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (the eMax Drill System, K011444). The FDA's 510(k) pathway is for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.
Therefore, many of the requested categories (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment here is primarily based on comparing the new device's specifications and performance to an already cleared predicate device, rather than an independent clinical study against a predefined set of performance metrics.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No explicit acceptance criteria or target performance values are defined in this document for the eMax 2 Plus System itself. The entire premise of a 510(k) is to demonstrate "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states that the eMax 2 Plus System is made of the same materials and contains features and functions similar to the currently available eMax Drill System (K011444). The same cutters, attachments, and accessories will interface with both systems. This implies that its performance is expected to be equivalent to the predicate device.
2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the context of a performance study for the eMax 2 Plus System. The evaluation is based on comparing its design and specifications to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as it's not a diagnostic AI/CADe device being evaluated.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a surgical drill, not an AI/CADe system for image interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The eMax 2 Plus System is cleared based on its substantial equivalence to the predicate eMax Drill System (K011444). The performance demonstration is implicitly through the assertion that the new device has technological characteristics similar to the predicate device, including materials, features, functions, and compatibility with accessories. The FDA's role in this 510(k) process is to confirm that these similarities allow the new device to be marketed without raising new questions of safety and effectiveness, assuming it meets general controls and manufacturing practices.
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510(k) Summary of Safety and Effectiveness
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 DrivePalm Beach Gardens, FL 33410 | K080802 |
|---|---|---|
| Official Correspondent | Jim BanicSenior Regulatory Affairs SpecialistThe Anspach Effort, Inc.4500 RiversidePalm Beach Gardens, FL 33410Tel. 561-627-1080Fax. 561-625-9110Email: jimb@anspach.com | |
| Date Prepared | March 17, 2008 | |
| Device Name | eMax 2 Plus System | |
| Classification Name | Motor, Drill, Electric | |
| DeviceClassification | Class IINeurology21 CFR § 882.4360 | |
| PredicateDevices | eMax Drill System-> K011444 | |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. | |
| Device Description | The eMax 2 Plus System is an electrically powered drillmotor with a series of attachments designed for use on thebones of the cranium and spine. The system componentsinclude a control console, the motor hand piece and footcontrol switch. The control console supplies power to themotor through a detachable cable. This system is non-sterile. | |
| Indications for Use | The eMax 2 Plus System is intended use is for Cutting andshaping bone including spine and cranium. | |
| TechnologicalCharacteristics | The eMax 2 Plus System is made of the same materials andcontains features and functions which are similar to thecurrently available eMax Drill System. The same cutters,attachments and accessories which interface with the eMaxDrill System will interface with the eMax 2 Plus System. | |
| Conclusion | The eMax 2 Plus System is substantially equivalent to thecurrently marketed eMax Drill System cleared by K011444on August 8, 2001. |
The Anspach Effort, 4500 Riverside Drive, Palm Beach Gardens, FL 33410
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The Anspach Effort, 4500 Riverside Drive, Palm Beach Gardens, FL 33410
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 3 0 2008
The Anspach Effort, Inc. % Mr. Jim Banic Senior Regulatory Affairs Specialist 4500 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K080802
Trade/Device Name: eMax 2 Plus System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric cranial drill motor Regulatory Class: II Product Code: HBC Dated: March 17, 2008 Received: March 31, 2008
Dear Mr. Banic:
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.
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.
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Page 2 - Mr. Jim Banic
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Mark N. Millman
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K080802_
Device Name: eMax 2 Plus System
Indications for Use:
The eMax 2 Plus System is intended for Cutting and shaping bone including 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K080802
§ 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).