(239 days)
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 contours in the craniofacial skeleton including the frontoorbital maler and mental areas.
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.
The provided text describes a 510(k) premarket notification for the DRG QuickMix Mixing System for BoneSource® Hydroxyapatite Cement (HAC). This document is focused on establishing substantial equivalence to a predicate device, rather than a clinical study proving the device meets specific acceptance criteria through measured performance.
Therefore, many of the requested sections about acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment are not present in this type of regulatory submission. The 510(k) summary primarily demonstrates that the new device is as safe and effective as a legally marketed predicate device.
Here's an breakdown of what can be extracted or inferred from the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device, not on presenting specific performance metrics against pre-defined acceptance criteria for the QuickMix system itself. The predicate device, BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit, would have had performance data, but that is not detailed here for the QuickMix mixing system.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the 510(k) summary. A 510(k) submission for a mixing system typically relies on demonstrating that the mixing process yields a material that meets the specifications of the cement itself, which would have been established for the predicate device. It doesn't detail a separate "test set" in the context of clinical trials or algorithm performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not present. The 510(k) summary for a mixing system does not involve establishing ground truth from expert consensus in the way a diagnostic AI device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not present. As above, the nature of this submission does not involve adjudication methods related to expert consensus on clinical data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable/not present. The device (a cement mixing system) is not an AI-powered diagnostic tool, and therefore MRMC studies or AI assistance metrics are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not present. The device is a physical mixing system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not present in the context of the QuickMix system itself. The system is a tool for preparing a medical material (BoneSource HAC). The performance validation would typically involve chemical and physical property testing of the mixed cement to ensure it meets specifications, rather than clinical ground truth as described.
8. The sample size for the training set
This information is not applicable/not present. The device is not an AI algorithm that requires a "training set."
9. How the ground truth for the training set was established
This information is not applicable/not present. As above, the device is a physical mixing system, not an AI algorithm.
Summary of what is present and its relevance:
- Acceptance Criteria & Performance: The document implicitly aims to demonstrate that the QuickMix Mixing System, when used with BoneSource HAC, produces a cement that is substantially equivalent in its properties and intended use to the predicate device (BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit distributed by Stryker Leibinger K991398). The performance would be related to the consistency and quality of the mixed cement, but specific metrics and acceptance criteria for this mixing system are not detailed in this summary. The "study" proving this would be a series of tests verifying the mixed cement's properties (e.g., setting time, strength, handling characteristics) match those of the predicate.
- Sample Sizes: Not relevant or provided for this type of submission.
- Experts/Ground Truth: Not relevant for this type of submission focused on a physical mixing device.
- Study Type: This is a 510(k) Premarket Notification document. The "study" isn't a traditional clinical trial as described in the prompt. It's a regulatory submission demonstrating substantial equivalence to a predicate device. This means showing that the QuickMix system does not raise different questions of safety and effectiveness than the previously cleared Stryker Leibinger system (K991398). This substantial equivalence is typically supported by bench testing, material characterization, and comparison of design and intended use, rather than large-scale human clinical trials or expert evaluation of outputs in the way a diagnostic device would.
{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
§ 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).