(35 days)
No
The device description focuses on mechanical and electrical components (console, handpieces, footswitch, speed controls, torque limiting, irrigation pump) and their functions (screw insertion, cutting, drilling, etc.). There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis capabilities. The "Not Found" entries for AI/ML mentions, training/test sets, and performance studies further support this conclusion.
Yes
The device is used for surgical procedures such as cutting, drilling, and shaping bones and teeth, which are therapeutic interventions.
No
The device description and intended use indicate it is a surgical tool used for various physical procedures like cutting, drilling, and shaping bones and teeth, not for diagnosing medical conditions.
No
The device description explicitly lists multiple hardware components including a console, handpieces, attachments, footswitch, and cutting tools.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Synthes Electric Pen Drive System is a surgical tool used for mechanical manipulation of bone and metal during surgical procedures. It drills, cuts, shapes, and smooths these materials.
- Lack of Biological Sample Analysis: The description does not mention the device analyzing any biological samples from the patient. Its function is purely mechanical and applied directly to the surgical site.
Therefore, the device's intended use and description clearly indicate it is a surgical instrument, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Synthes Electric Pen Drive (EPD) System 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 but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery.
Product codes
HWE, DZI, ERL, HBE
Device Description
The Synthes Electric Pen Drive System consists of a console, handpieces, attachments, footswitch, and cutting tools. The console is connected to the mains by an electric cord, and includes connectors for the handpieces and the footswitch, as well as speed controls, torque limiting feature, and irrigation pump. The handpieces are pen-shaped, and will be available in two versions: 60,000 rpm and 90,000 rpm. The handpieces are connected to the console via a sterilizeable cord. The rotation speed of the motor can be controlled via the footswitch or a removable handswitch. Multiple attachments are available that have a quick-connect into the handpieces; these 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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.
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JAN - 5 2005
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| 3.0 | 510(k) Summary | Page 1 of 1 | |
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| Sponsor: | Synthes (USA) 1690 Russell Road Paoli, PA 19301 (610) 647-9700 | ||
| Device Name: | Synthes Electric Pen Drive (EPD) 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 882.4360: Electric cranial drill motor Instrument, surgical, orthopedic, AC-powered motor & accessories | ||
| Predicate Device: | Stryker Total Performance (TPS) System | ||
| Device Description: | The Synthes Electric Pen Drive System consists of a console, handpieces, attachments, footswitch, and cutting tools. The console is connected to the mains by an electric cord, and includes connectors for the handpieces and the footswitch, as well as speed controls, torque limiting feature, and irrigation pump. The handpieces are pen-shaped, and will be available in two versions: 60,000 rpm and 90,000 rpm. The handpieces are connected to the console via a sterilizeable cord. The rotation speed of the motor can be controlled via the footswitch or a removable handswitch. Multiple attachments are available that have a quick-connect into the handpieces; these attachments accept various cutting tools, including drill bits, burrs and saw blades. | ||
| Intended Use: | The Synthes Electric Pen Drive (EPD) System 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 but not limited to general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery. | ||
| Substantial Equivalence: | Comparative information presented supports substantial equivalence. | ||
| The term "substantial equivalence" as used in this 510(k) notification is limited to the definition of substantial equivalence found in the Federal Food, Drug and Cosmetic Act, as amended and as applied under 21CFR 807, Subpart E under which a device can be marketed without premarket approval or reclassification. A determination of substantial equivalency under this notification is |
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not intended to have any bearing whatsoever on the resolution of patent infringement suits or any other patent matters. No statements related to, or in support of substantial equivalence herein shall be construed as an admission against interest under the US Patent Laws or their application by the courts.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2005
Ms. Lisa M. Boyle Regulatory Specialist Synthes (USA) 1690 Russell Road Paoli, Pennsylvania 19301
Re: K043310
Trade/Device Name: Synthes (USA) Electric Pen Drive (EPD) System Regulation Number: 21 CFR 882.4310, 21 CFR 874.4250 Regulation Name: Powered simple cranial drills, burrs, trephines and accessories Regulatory Class: II Product Code: HWE, DZI, ERL, and HBE Dated: December 17, 2004 Received: December 20, 2004
Dear Ms. Boyle:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrobars) (c regists) at the Medical Device Amendments, or to conniner of the to 1125 2011 and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmeter Fer (10) and as device, subject to the general controls provisions of the Act. The r ou may, dicrororo, maines of the Act include requirements for annual registration, listing of general vonators pro resuring 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 If your device is onastined (600 as controls. Existing major regulations affecting your device can may be subject to back additions, 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 I Teast be advised that I Dris issually vour device complies with other requirements of the Act that I Dr has Interves and regulations administered by other Federal agencies. You must or any I cacal statutes and registments, including, but not limited to: registration and listing (21 Comply with an the Her 610 care 101 ); good manufacturing practice requirements as set CFR Part 807); adomig (21 CFR Part 820); and if applicable, the electronic forul in the quality bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Lisa M. Boyle
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and in your a FDA finding of substantial equivalence of your device to a legally premated 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 rr you dome specific as reliance 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 other general informational 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,
for 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
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2.0 Indications for Use
| 510(k) Number (if known): | k 04 3310 |
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| --------------------------- | ----------- |
Device Name:
Synthes (USA) Electric Pen Drive (EPD) System
Indications for Use:
The Synthes Electric Pen Drive (EPD) System 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 but not limited to 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)
Muriam C. Provost
Division of General, Restorative, and Neurological Devices
K043310 510(k) Number.