(168 days)
The Synthes Air Pen Drive (APD) is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery
The Synthes Air Pen Drive (APD) System is a pneumatic powered system that consists of a Foot Pedal, Drive Unit, Hand Switch and Irrigation Control Unit that may be used with various commercially available attachments and cutting tools. The Drive Unit is pen-shaped and is connected to the Foot Pedal via a sterilizeable air hose. The rotation speed of the Drive Unit may be controlled from 0 to 60,000 rpm at 8 bar and from 0 to 80,000 at 12 bar via the Foot Pedal or the removable Hand Switch. Multiple attachments are available that have a quick-connect coupling to attach to the Drive Unit. The attachments accept various cutting tools including drill bits, burrs and saw blades.
This document describes a 510(k) summary for the Synthes Air Pen Drive (APD) System, a pneumatic powered surgical drill system. The entire document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study to prove a device meets specific performance acceptance criteria for an AI/ML powered device.
Therefore, many of the requested categories about acceptance criteria and AI/ML study design cannot be extracted from the provided text.
Here is the information that can be extracted or explicitly stated as not present:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality | Passed functionality testing |
| Reliability | Passed reliability testing |
| Duty cycle | Passed duty cycle testing |
| Wear of couplings, valves, hoses, and seals | Passed wear testing |
| Leakage of couplings, valves, hoses, and seals | Passed leak testing |
| Endurance of switches and valve control | Passed endurance testing |
| Noise | Passed noise testing |
| Temperature | Passed temperature testing |
| Output torque | Comparable to predicate device (Synthes Electric Pen Drive (EPD) System (K043310) and Midas Rex Legend System (K020069)) |
| Power | Comparable to predicate device (Synthes Electric Pen Drive (EPD) System (K043310) and Midas Rex Legend System (K020069)) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a medical device (surgical drill) and the testing involved non-clinical performance and engineering evaluations, not studies on a test set with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. Ground truth for a diagnostic AI/ML device is not relevant here as this is a surgical drill. The evaluation was based on engineering performance and adherence to standards.
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 is not an AI/ML powered device for diagnostic or analytical purposes.
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. The "ground truth" for this device's evaluation was based on established engineering principles, industry standards for medical devices, and performance characteristics of predicate devices.
8. The sample size for the training set:
Not applicable. This is not an AI/ML powered device.
9. How the ground truth for the training set was established:
Not applicable.
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K 893361
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APR 1 4 2010
3.0 510(k) Summary
Page _ of __ of ___________________________________________________________________________________________________________________________________________________________________ 1
| Sponsor:Contact:Date of Preparation: | Synthes (USA)1301 Goshen ParkwayWest Chester, PA 19380 Phone: (610) 719-6538Jill R. Yelton, Regulatory Compliance ManagerOctober 26, 2009 |
|---|---|
| Device Name: | Synthes Air Pen Drive (APD) System |
| Classification: | 21 CFR 872.4120: Drill, bone, powered21 CFR 874.4250: Drill, surgical, ENT (Electric or Pneumatic21 CFR 882.4310: Powered simple cranial drills, burrs, trephines, andaccessories21 CFR 882.4370: Pneumatic cranial drill motor |
| Predicate Device: | Synthes Electric Pen Drive (EPD) System (K043310)Midas Rex Legend System (K020069) |
| Device Description: | The Synthes Air Pen Drive (APD) System is a pneumatic poweredsystem that consists of a Foot Pedal, Drive Unit, Hand Switch andIrrigation Control Unit that may be used with various commerciallyavailable attachments and cutting tools. The Drive Unit is pen-shapedand is connected to the Foot Pedal via a sterilizeable air hose. Therotation speed of the Drive Unit may be controlled from 0 to 60,000rpm at 8 bar and from 0 to 80,000 at 12 bar via the Foot Pedal or theremovable Hand Switch. Multiple attachments are available that havea quick-connect coupling to attach to the Drive Unit. The attachmentsaccept various cutting tools including drill bits, burrs and saw blades. |
| Intended Use: | The Synthes Air Pen Drive (APD) is indicated for screw insertion, pinand wire placement, cutting of bone and metal, drilling, reaming,decorticating, shaping and smoothing of bones and teeth in a widevariety of surgical procedures, including general orthopedic trauma,foot, hand, maxillofacial, neurosurgical, oral, otolaryngological,reconstructive and spine surgery. |
| SubstantialEquivalence: | Information presented supports substantial equivalence of theproposed device to the predicate device. The proposed device has thesame indications for use, incorporates the same fundamental producttechnology and is composed of the same materials. Non-clinicaltesting was performed in accordance with current standards forfunctionality and reliability of the proposed device. Testing includes;duty cycle testing, wear and leak testing of couplings, valves hosesand seals, endurance testing of switches and valve control, noisetesting and temperature testing. Additionally, engineeringperformance evaluation and analysis was performed comparing outputtorque and power of the proposed device to the predicate device. |
. .
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
APR 1 4 2010
Synthes (USA) % Ms. Jill R. Yelton Regulatory Compliance Manager 1301 Goshen Parkway West Chester, Pennsylvania 19380
Re: K093361
Trade/Device Name: Synthes Air Pen Drive (APD) System Regulation Number: 21 CFR 872.4120 Regulation Name: Regulatory Class: Class II Product Code: HBB Dated: April 07, 2010 Received: April 08, 2010
Dear Ms. Yelton:
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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Ms. Jill R. Yelton
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.0 Indications for Use
| 510(k) Number (if known): | K093361 |
|---|---|
| Device Name: | Synthes Air Pen Drive (APD) System |
| Indications for Use: |
The Synthes Air Pen Drive (APD) is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery
X Prescription Use (Per 21 CFR 801.109)
AND/OR
Over-The-Counter Use_ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nui R.P. Oglumfsmkn
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093361
000004
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).