(239 days)
No
The device description details a manual mixing system for bone cement and solution, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
The device is a mixing system for a bone cement and solution, it does not directly provide therapy to a patient.
No
The device is described as a mixing system for bone cement, used for repair and augmentation of bony contours. Its function is to prepare the cement, not to diagnose medical conditions.
No
The device description clearly outlines physical components (syringes, filter, cement, solution) and a manual mixing process, indicating it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to mix a bone cement and a solution for the repair and augmentation of bony defects in the craniofacial skeleton. This is a surgical/procedural use, not a diagnostic one.
- Device Description: The device is a mixing system for preparing a material to be implanted or applied to a patient's bone. It does not involve testing samples from the human body to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting markers, or providing information about a patient's health status or disease.
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 QuickMix device is used to prepare a material for direct application to the patient's body during a surgical procedure.
N/A
Intended Use / Indications for Use
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. The cement is indicated for use in the repair of neurosurgical burr holes, contiquous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
Product codes
GXP, FWP, LZK
Device Description
The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it.
The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgical burr holes, contiguous craniotomy cuts, cranial, craniofacial skeleton including the fronto-orbital maler and mental areas.
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
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).
0
Premarket Notification 510(k) Summary of Safety and Effectiveness DRG QuickMix
JAN 2 9 2002
Company Information
Doctors Research Group, Inc. 50 Altair Ave. Plymouth, CT 06782 Phone: 800-371-2535 Fax: 860-283-1589
Contact: Richard Deslauriers, MD
Registration Number: 1226001
Summary Preparation Date
May 31, 2001
Device Information
| Trade Name: | QuickMix Mixing System for BoneSource® Hydroxyapatite Cement (HAC) |
|---|---|
| Common Name: | Hydroxyapatite Cement (HAC) |
| Classification Name: | Methyl Methacrylate for Cranioplasty |
| Device Classification Panel: | Neurology |
| Regulation Number: | 21CFR Part 882.5300 |
| Class: | II |
| Product Code: | GXP |
1
Predicate Device
The DRG QuickMix mixing system is substantially equivalent to the BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit distributed by Stryker Leibinger (K991398), which contains BoneSource® Hydroxyapatite Cement powder, one (or two based on the size of the kit) prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are provided in sizes ranging form 2.5g to 50g.
Device Description
The DRG QuickMix mixing system consists of a syringe containing a 0.25 M sodium phosphate solution and a mixing syringes containing BoneSource® Hydroxyapatite Cement. The mixing syringe also contains a filter which allows liquid, but not the cement mixture, to pass through it.
The sodium phosphate and cement mixing syringes are first connected tip to tip. The sodium phosphate solution is then injected into the mixing syringes and the cement mixture is shaken to thoroughly blend it. Excess liquid is then pulled from the mixing chamber through the filter assembly by retracting the solution plunger. The two syringes are then disconnected. The filter cap is then removed from the mixing syringe and the mixture is eiected.
| Mixing Syringe, cc | BoneSource, g | .25 M Sodium Phosphate, mL |
|---|---|---|
| 5 | 2.5 | 2.25 |
| 10 | 5.0 | 4.5 |
| 20 | 10.0 | 9.0 |
| 50 | 25.0 | 22.5 |
| 100 | 50.0 | 45.0 |
Kits are being provided in five sizes:
Indications for Use
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. The cement is indicated for use in the repair of neurosurgical burr holes, contiquous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm2 per defect, and for augmentation or restoration of bony contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 3 0 2002
Richard Deslauriers, M.D. President Doctors Research Group, Inc. 143 Wolcott Road Wolcott, Connecticut 06716
Re: K011736
Roll 750
Trade/Device Name: QuickMix Mixing System for BoneSource® Trade Dovice Intern 21 CFR 882.5300 and 878.3550 Regulation Name: methyl methacrylate for cranioplasty; prosthesis, chin, internal; and implant, malar Regulatory Class: II
Product Code: GXP, FWP and LZK Dated: November 28, 2001 Received: November 28, 2001
Dear Dr. Deslauriers:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 910(x) premainted is substantially equivalent (for the indications for use stated in the enclosure) the arrested predicate devices marketed in interstate for use stated in the encrosule) to regally manatinent patice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the chaochance with the provisions of the Federal Food. Drug, devices that have been recassified in accessaries will a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previous of the Act. and Cosmetic Act (Act) that do not require approval controls provisions of the Act. The
You may, therefore, market the device, subject to the general provisions of the Act. You may, therefore, market the dovice, basics of the most mister interests michaeding and general controls provisions of the rice merace requires 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 classified (Scc above) mis existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may be subject to such additional controlis. Extronic of one of the 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Ood of I casial Ing your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a succession of the requirements of the Act
that FDA has made a determination that your device complies with of the Act that FDA has made a decionmation and Journer Federal agencies. You must and of any Federal statutes and regulations danimations of the registration and listing (2) .
comply with all the Act's requirements, including, but not limited to: ref comply with an the Act 3 requirements, mercesses on anufacturing practice requirements as setter CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and 11 app 1050 forth in the quality systems (QD) regalances (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
3
Page 2 - Richard Deslauriers, M.D.
This letter will allow you to begin marketing your device as described in your Section 510(k)
Contraction of the FDA finding of substantial equivalence of your device to a l This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA finding of subscification for your device to a legally premarket notification. The FDA finding of substantial equivalité of 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 If you desire specific advice for your device on our labelling regulation (as onlice of
additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the O additionally 21 CFR Part 809.10 for in vitro diagnostic devices), promotion and advertising of
Compliance at (301) 594-4659. Additionally, for questions on the promotion and Compliance at (301) 594-4659. Additionally, for questions on uncluded to the one of the enterest of the your device, please contact the Office of Compliation of Corry of City of Cler. Part 807.97).
regulation entitled, "Misbranding by reference to premarket may be otained from regulation entitled, "Misbranding by reference to premarket hot may be obtained from the Other general information on your responsibilites under the Accument of Schools.
Division of Small Manufacturers, International and Consumer Assistance at its toll-free numbe Division of Small Manufacturers, Increasing Internet address
(800) 638-2041 or (301) 443-6597 or at its Internet address
1800) 638-2041 or (301) 443-659 (1) versain html (600) 058-2011 01 (2011-01-11)
Sincerely yours,
Mark n Mulkener
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
4
Doctors Research Group, Inc. 143 Wolcott Road Wolcott, CT 06716 (203) 879-9422
Statement of Indications For Use
510(k) Number (if Known):
QuickMix Mixing System for BoneSource® Hydroxyapatite Device Name: Cement (HAC)
Indications for use:
QuickMix is indicated for use in mixing BoneSource® Hydroxyapatite Cement and sodium phosphate solution. BoneSource is indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25 cm² per defect, and for augmentation or restoration of bony contour in the craniofacial skeleton including the fronto-orbital maler and mental areas.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEI Concurrence of CDRH, Office of Device Evaluation (ODE)
for Mark n Millkener
Division Sign Off
Division of General. R = orative and Neurological Devices
510(k) Number K011736
Prescription Use ي (Per 21 CFR 801.109) OR
Over-The-Counter Use