(168 days)
No
The description focuses on the mechanical and pneumatic aspects of the device, with no mention of AI or ML capabilities.
No
A therapeutic device is used to treat or alleviate a disease or condition. This device is used for surgical procedures like cutting, drilling, and shaping bones and teeth, which are actions to prepare or modify the anatomy, not to directly treat a disease or condition.
No
Explanation: The device is described as a pneumatic-powered system used for various surgical procedures involving cutting, drilling, and shaping bones and teeth, which are interventional actions, not diagnostic ones.
No
The device description clearly outlines a pneumatic powered system with physical components like a Foot Pedal, Drive Unit, Hand Switch, and Irrigation Control Unit, which are hardware.
Based on the provided information, the Synthes Air Pen Drive (APD) is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly describes a device used during surgical procedures on bones and teeth for mechanical actions like cutting, drilling, and shaping. This is a surgical tool, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a pneumatic powered system with a handpiece, foot pedal, and various attachments for surgical tools. This aligns with a surgical instrument, not an IVD device which typically involves reagents, analyzers, and testing of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Synthes Air Pen Drive does not perform any of these functions.
N/A
Intended Use / 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.
Product codes
HBB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bones and teeth
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)
Non-clinical testing was performed in accordance with current standards for functionality and reliability of the proposed device. Testing includes; duty cycle testing, wear and leak testing of couplings, valves hoses and seals, endurance testing of switches and valve control, noise testing and temperature testing. Additionally, engineering performance evaluation and analysis was performed comparing output torque and power of the proposed device to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Synthes Electric Pen Drive (EPD) System (K043310)
Reference Device(s)
Midas Rex Legend System (K020069)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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K 893361
Image /page/0/Picture/8 description: The image shows the word "SYNTHES" in bold, black letters. To the left of the word is a circular logo with a design inside. There is a horizontal line underneath the word "SYNTHES".
APR 1 4 2010
3.0 510(k) Summary
Page _ of __ of ___________________________________________________________________________________________________________________________________________________________________ 1
| Sponsor:
Contact:
Date of Preparation: | Synthes (USA)
1301 Goshen Parkway
West Chester, PA 19380 Phone: (610) 719-6538
Jill R. Yelton, Regulatory Compliance Manager
October 26, 2009 |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Synthes Air Pen Drive (APD) System |
| Classification: | 21 CFR 872.4120: Drill, bone, powered
21 CFR 874.4250: Drill, surgical, ENT (Electric or Pneumatic
21 CFR 882.4310: Powered simple cranial drills, burrs, trephines, and
accessories
21 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 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. |
| Intended 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. |
| Substantial
Equivalence: | Information presented supports substantial equivalence of the
proposed device to the predicate device. The proposed device has the
same indications for use, incorporates the same fundamental product
technology and is composed of the same materials. Non-clinical
testing was performed in accordance with current standards for
functionality and reliability of the proposed device. Testing includes;
duty cycle testing, wear and leak testing of couplings, valves hoses
and seals, endurance testing of switches and valve control, noise
testing and temperature testing. Additionally, engineering
performance evaluation and analysis was performed comparing output
torque and power of the proposed device to the predicate device. |
. .
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird in flight, with three wing-like shapes suggesting movement. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font. The text is arranged around the circumference of the circle, with the bird facing towards the text.
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
2
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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Image /page/3/Picture/0 description: The image shows the word "SYNTHES" in a bold, sans-serif font. To the left of the word is a circular logo with a design inside. A registered trademark symbol is located to the right of the word. A horizontal line is located underneath the word.
Page 1 of 1
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