(292 days)
For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.
The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction.
There are many unique features that make this distractor an improvement over those currently available. The main advantages over other devices include its' smaller size and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not require any adjustment or addition of parts. The alloy metals used provide for excellent stability.
In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones.
The provided document is a 510(k) summary for the NewMedical Micro Bone Distractor/Fixator. It describes the device, its intended use, materials, design, and operational principles, and states its substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria, device performance results, sample sizes for test or training sets, ground truth establishment, or clinical study design elements (like MRMC studies or expert qualifications).
Therefore, I cannot fulfill the request for information on acceptance criteria and the study that proves the device meets them based solely on the provided text.
The rejection letter from the FDA (pages 2-4) also reiterates the substantial equivalence determination but does not provide performance data.
The document focuses on demonstrating substantial equivalence to existing devices rather than presenting detailed performance data against specific acceptance criteria.
To provide the requested information, a different type of document, such as a full clinical study report or a detailed performance validation report, would be necessary.
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DEC - 3 2003
510(k) Summary
Image /page/0/Picture/3 description: The image shows the words "New medical Technology" in a stylized font. The word "New" is in a larger, bold font, while "medical" is in a smaller, regular font. The word "Technology" is in an even smaller, italicized font and is placed below the word "medical". The text appears to be part of a logo or heading.
NewMedical Technology, Inc
N.14 W.23833 Stone Ridge Dr. Suite G100 Waukesha, WI 53188 USA 262- 523 0521 Main 262- 513 0799 Fax 262-391 7899 Mobile
| Date of Submission: | February 10 , 2003 |
|---|---|
| Submitted by: | Haitham Matloub,Senior Engineer, Research and Development |
The micro distractor/external fixator introduced by NewMedical Technology, Inc., is a device which is substantially equivalent to other external fixators /distractors. Its indications for use are substantially the same, that is, external fracture fixation and/or distraction.
There are many unique features that make this distractor an improvement over those currently available. The main advantages over other devices include its' smaller size and lightweight construction. The recessed distraction actuating screw is tamper resistant and hence better for use in pediatric patients. The device can only be actuated with the use of a custom actuator which is provided in the kit with the device. Hence, this tamper resistant design is useful when the device is used as an external bone fixation device for the treatment of fractures. Similarly, the conversion to a static from a dynamic fixator does not require any adjustment or addition of parts. The alloy metals used provide for excellent stability.
In summary, the features incorporated into the NewMedical Micro Distractor/External Fixator have specific advantages over other substantially equivalent products to enhance ease of placement along with the care and comfort of the patient requiring external fixation/distraction of the mandible or small bones.
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Equivalence To Marketed Devices:
Equivalency of the NewMedical Micro Distractor/Fixator Device, is based on similarities in intend use, materials, design and operational principles to the predicate external distractor (fixation devices.
The design features of the NewMedical Micro Distractor/Fixator Device, and the named me ucate devices are substantially equivalent as these devices attach to bone and move the bone outward when mechanical distraction forces are applied. In addition to moving bones, the bone outherity which mochantially equivalent to the named derives in stabilizing fractured bone structures.
1-Intended Use:
All of the named devices, and the NewMedical Micro Distractor/Fixator Device, are intended to All of the number on fixation/ distraction devices for the stabilization/lengthening of bone and bone fragments.
2-Materials:
The materials used in the manufacturing of the NewMedical Micro Distractor/Fixator Device, rne two grades of Stainless steel. The material conforms to ASTM F 138-97. Gold plating and Electro polishing are applied to all device components. Stainless steel and gold materials have long history of successful clinical usage. Stainless steel is used in the manufacture of the Hoffman Mini Fixator, Synthes Mini-Lengthener and the Mandibular Bone Lengthener.
Lengthening screw Stainless Steel 316L/gold plating Locking set screws: SS 18-8/gold plating . Guide rods ( rails) SS 316L/Gold plating Body SS 316 L/Gold palting
3- Design:
The basic design features of the NewMedical Micro Distractor/Fixator Device are substantially equivalent to the predicate devices. The subject device and the named derives accept various diameter pins. The subject device and the named devices operate using the same principle by utilizing screw mechanism that the surgeon adjusts to control the distraction/compression length. The subject device and the predicate devices use clamps attached to the distraction screw for holding the pins or threaded wires. Distraction/compression occurs by turning the screw shaft clockwise or counter clockwise causing attached clamps to slide along the axial axis of the screw shaft.
Lengthening screw Stainless Steel 316L,
Locking set screws: SS 18-8/gold Guide rods ( rails) SS 316L Body SS 316 L
4- Operational Principles:
The basic operational principles for the named device and the subject device are similar - mainly in site preparation, pin placement and device operation. The bone distraction/compression is similar also.
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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with healthcare, featuring a staff with a serpent entwined around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 3 2003
Ms. Haitham Matloub Senior Engineer, Research and Development N.14 W.23833 Stone Ridge Drive, suite G100 Waukesha, Wisconsin
Re: K030485
Trade/Device Name: NewMedical Micro Bone Distractor / Fixator Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: October 23, 2003 Received: October 3, 2003
Dear Ms. Matloub:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becatermined the device is substantially equivalent (for the Itelerenced anove and have accemningsure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device micrstate conmiseres prior to may 20, 20, 2017 accordance with the provisions of Amendinents, or to actrices that metic Act (Act) that do not require approval of a premarket the rederal I ood, Drag, the Commay, therefore, market the device, subject to the general approvincianon (1 the Act. The general controls provisions of the Act include condors provisions of this of the 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 If your device is classified (such additional controls. Existing major regulations affecting (FMA), It may be subject to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be roundsh further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Matloub
Please be advised that FDA's issuance of a substantial equivalence determination does not Flease be advisod that I Dr to loballios on that your device complies with other requirements Incall that FDA has made a actession and regulations administered by other Federal agencies. of the Act of ally I ederal bata suirements, including, but not limited to: registration r ou must comply with and the rised ing (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Part 807), equality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in are quartify in control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow yourse of substantial equivalence of your device to a premits the motivement. The PDF 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), 11 you desire speome at 1301) 594-4613. 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 may other gener generalacturers, International 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,
Patricia Cucurullo for
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
K030485 510(k) Number (if known):
Device Name: NewMedical Micro Bone Distractor/Fixator
Indications for Use:
For pediatric patients, for external fixation of mandibular fractures or for mandibular distraction.
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susa Rusane
gy, General Hospital,
510(k) Number. K.03
Page 1 of 1
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.