(16 days)
Not Found
No
The 510(k) summary describes a mechanical bone distractor and makes no mention of AI or ML technology.
Yes
The device is described as a "bone stabilizer" and "distraction device" used for correcting congenital deficiencies or post-traumatic defects in bone, indicating a therapeutic purpose.
No
Explanation: The device is described as a "bone stabilizer and distraction device" used for correcting congenital deficiencies or post-traumatic defects. Its function is to gradually distract bone, which is a therapeutic intervention, not a diagnostic one.
No
The device description explicitly states it is a "distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws," indicating it is a physical hardware device.
Based on the provided information, the Lorenz BLUE Device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a bone stabilizer and distraction device used for gradual correction of bone defects. This is a mechanical function performed directly on the patient's body.
- Device Description: The description confirms it's a distractor with a drive screw mechanism and external frame attached to the patient. This is a physical device used for surgical intervention.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body to provide information about a person's health. IVDs are typically used for diagnosis, monitoring, or screening based on laboratory tests.
Therefore, the Lorenz BLUE Device falls under the category of a surgical or orthopedic device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).
Product codes (comma separated list FDA assigned to the subject device)
MQN
Device Description
The Lorenz BLUE Device is a distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) SUMMARY (per 21 CFR 807.92(c))
1. SUBMITTER
Walter Lorenz Surgical, Inc. 1520 Tradeport Drive Jacksonville, FL 32218 FDA Registration No. 1032347
2. PRODUCT NAME
Common/Usual Name: Bone Lengthening Device/Plate, Fixation, Bone
Proprietary Name: Lorenz BLUE Device
-
- DEVICE CLASSIFICATION
Bone Lengthening Devices have been cleared by the FDA via 510(k) Premarket Notifications as Product Code MQN, External Distractor -Class II. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic act for External Distractors.
- DEVICE CLASSIFICATION
4. PREDICATE DEVICE
The predicate device is the Lorenz Distraction System cleared under 510(k) number K992952 on November 19, 1999.
న్. DESCRIPTION OF THE DEVICE
The Lorenz BLUE Device is a distractor that has a drive screw mechanism and external frame that is rigidly attached to the patient with cranial screws.
INTENDED USE OF THE DEVICE 6.
The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when correction of congenital deficiencies or post traumatic defects of oral (including the mandible, alveolar ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction.
009626
1
7. STATEMENT OF COMPARISON OF TECHNOLOGICAL FEATURES
Although the appearance of these devices is different; the implantable portions, implantable materials, the fundamental operating mechanism, the activation, and the intended use of these devices is the same. Attachment to the transporting bone segment is accomplished with internal plates and bone screws in each system. The modified device is being added to allow for additional options for screw placement in areas of good bone quality and improved vector control.
8. CONCLUSIONS
The use of the modified Lorenz BLUE Device and the predicate Lorenz Distraction System as bone lengthening devices is substantially similar.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Ms. Kim Reed Regulatory Specialist Walter Lorenz Surgical, Incorporated 1520 Tradeport Drive Jacksonville, Florida 32218
Re: K020407
Trade/Device Name: Lorenz Blue Device Regulation Number: 872.4760 Regulation Name: Bone Plate Regulatory Class: II Product Code: MQN Dated: February 5, 2002 Received: February 6, 2002
Dear Ms. Reed:
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.
3
Page 2 - Ms. Reed
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.
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
STATEMENT OF INDICATIONS FOR USE
510(k) Number: K020407
Device Name: Lorenz BLUE Device
Indications For Use:
The Lorenz BLUE Device is intended as a bone stabilizer, and distraction devices when The Dolonia DEGE Dongenital deficiencies or post traumatic defects of oral (including the conton of ochigenear ridge, palate, and symphysis areas), cranial, and maxillo-facial bone require gradual distraction. This is the same intended use as previously cleared for the Lorenz Distraction System (K992952).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter-Use Prescription Use ..
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Susan Parry
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devissage 510(k) Number -
0000014