(70 days)
The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).
The AutoloGel Process Centrifuge consists of a table-top, non self-decanting, rotor spin centrifuge and processing disposables designed to allow for rapid automatic separation of plasma and red blood cells from a small volume of whole blood. The centrifuge spins at a maximum speed of 7200 rpms producing a maximum force of approximately 4227 g.
This is a 510(k) summary for a medical device called the "AutoloGel Process Centrifuge." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than establishing new acceptance criteria or conducting extensive performance studies like those typically seen for AI/ML devices. Therefore, many of the requested fields are not applicable or cannot be extracted from this type of submission.
Here's a breakdown of the information based on the provided text, with explanations where fields are not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
Formal acceptance criteria, as one might see for performance metrics (e.g., sensitivity, specificity for an AI diagnostic), are not presented in this 510(k). The submission focuses on comparing the technological characteristics of the AutoloGel Process Centrifuge to predicate devices. The "performance" reported is inherent in its design specifications and its ability to achieve its intended use, which is to rapidly separate platelet-rich plasma (PRP).
| Feature | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (AutoloGel Process Centrifuge) |
|---|---|---|
| Intended Use | Preparation of autologous platelet-rich plasma (PRP) from a small sample of patient's blood (up to 60 ml) at point-of-care. | Designed for the safe and rapid preparation of autologous PRP from a small sample of the patient's blood (up to 60 ml) at the patient's point of care. |
| Principles of Operation | Separation based on density of liquids | Separation based on density of liquids |
| Table-Top | Yes | Yes |
| Refrigerated | No | No |
| Micro-Processor Controlled | Yes | Yes |
| User Programmable | No (for similar predicate) | No, preset by manufacturer |
| Speed Control | Preset (for similar predicate) | Preset |
| Acceleration and Braking | Current-controlled | Current-controlled |
| Maximum RPM | Comparable to predicate devices (e.g., 6000 RPM, 3400 RPM) | 7200 RPM |
| Maximum RCF | Comparable to predicate devices (e.g., 3550 g, 2050 g) | 4227 g |
| Tube Capacity | Various internal sizes, maximum 60 ml | Various sizes, maximum 60 ml |
| Lid Locking, Lid Holding | Yes | Yes |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) is for a general-purpose centrifuge, not an AI/ML device that would typically have a "test set" in the context of performance evaluation. The submission refers to performance data as "not provided" for this section (presumably because it's a mechanical device where performance is demonstrated through engineering specifications and comparison to predicates, not through clinical trials or retrospective data analysis of diagnostic outputs).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As this is not an AI/ML diagnostic or predictive device, there is no "ground truth" established by experts in the context of image interpretation or diagnostic accuracy.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
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
Not applicable. This is not an AI-assisted device for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic device.
7. The Type of Ground Truth Used
Not applicable. The "ground truth" for a centrifuge relates to its physical performance (e.g., achieving specified RPMs, RCFs, separation efficiency). This is demonstrated through engineering testing and design specifications, not through a "ground truth" methodology as used in AI/ML performance studies.
8. The Sample Size for the Training Set
Not applicable. This device is not developed using machine learning, so there is no training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set.
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Original 510(k) Notification
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CONFIDENTIAL
D. 510(K) SUMMARY
KO 30340
APR 11 2003
510K Summary for the AutoloGel Process Centrifuge
| Submitter's Name and Address: | Cytomedix, Inc1523 S. Bowman Road, Suite ALittle Rock, AR 72211 |
|---|---|
| Phone Number: | 501-219-2111 |
| Fax Number: | 501-219-2114 |
| Contact Person: | Carelyn P. FyllingVice President of Professional Services218-547-4142 (o)501-352-1184 (cell)fylling@eot.com |
| Date Summary Prepared: | January 20, 2003 |
| Device Trade Name: | AutoloGel Process Centrifuge |
| Common Name: | General purpose centrifuge |
| Classification Name: | General purpose laboratory equipment labeled or promotedfor a specific medical use(21 CFR 862.2050) - Class I |
| Product Code: | JQC[Centrifuges (Micro, Ultra, Refrigerated) for Clinical Use] |
| Substantial Equivalence: | The proposed device is substantially equivalent to othertable-top centrifuges previously cleared by the FDA via the510K Notification process. Two predicative centrifuges havebeen identified: Harvest Technologies, LLC., SmartPrepCentrifugation System (K991430) and 3i Models 7426 and7437 CelSep Centrifuge System (K994148). |
| Device Description: | The AutoloGel Process Centrifuge consists of a table-top,non self-decanting, rotor spin centrifuge and processingdisposables designed to allow for rapid automatic separationof plasma and red blood cells from a small volume of wholeblood. The centrifuge spins at a maximum speed of 7200rpms producing a maximum force of approximately 4227 g. |
| Intended Use: | The AutoloGel Process Centrifuge is designed to be used atthe patient's point of care for the safe and rapid preparationof autologous platelet-rich plasma (PRP) from a small sampleof the patient's blood (up to 60 ml). |
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Technological Characteristics:
The proposed device has the same technological characteristics and is similar in design and configurations compared with the predicate devices. (See Table A)
| Table A | |||
|---|---|---|---|
| Comparison of The AutoloGel Process Centrifuge with the Predicative Devices | |||
| Features | CytomedixAutoloGel ProcessCentrifuge(This submission) | Harvest SmartPrepCentrifuge SystemK991430 | 3i CelSepK994148 |
| Intended Use | To be used at thepatient's point-of-carefor the safe and rapidpreparation ofautologous platelet-rich plasma (PRP)from a small sampleof the patient's blood(up to 60 ml). | To be used in theclinical laboratory orintraoperatively atpoint-of-care for thesafe and rapidpreparation of plateletpoor plasma andplatelet concentratefrom a small sampleof blood. The plasmaand concentratedplatelets produced canbe used for diagnostictests. | For use in the clinicallaboratory orintraoperatively atpoint-of-care for thesafe and rapidpreparation of plateletpoor plasma andplatelet concentratefrom a small sample(50 - 60 ml of wholeblood. The plasmaand concentratedplatelets produced canbe used for diagnostictests. |
| Principles ofOperation | Separation based ondensity of liquids | Separation based ondensity of liquids | Separation based ondensity of liquids |
| Table-Top | Yes | Yes | Yes |
| Refrigerated | No | No | No |
| Swinging Bucket | No, fixed angle rotor | Yes | Yes |
| Automatic Decanting | No | Yes | No |
| Micro-ProcessorControlled | Yes | Yes | Yes |
| User Programmable | No, preset bymanufacturer | No, preset bymanufacturer | Yes |
| Speed Control | Preset | Preset | Selectable |
| Acceleration andBraking | Current-controlled | Current-controlled | Current-controlled |
| Maximum RPM | 7200 RPM | 6000 RPM | 3400 RPM |
| Maximum RCF | 4227 g | 3550 g | 2050 g |
| Tube Capacity | Various sizes,maximum 60 ml | Two ProcessingDisposables (50 ml/disposable) | 1 Disposable60 ml/disposable |
| Lid Locking, LidHolding | Yes | Yes | Yes |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Druq Administration 2098 Gaither Road Rockville MD 20850
Ms. Carelyn P. Fylling Vice President for Professional Services Cytomedix, Inc. 1523 S. Bowman Road - Suite A Little Rock, AR 72211
APR 1 1 2003
Re: K030340 Trade/Device Name: AutoloGel Process Centrifuge Regulation Number: 21 CFR 862.2050 Regulation Name: General purpose laboratory equipment labeled or promoted for a specific medical use Regulatory Class: Class I Product Code: JOC Dated: January 31, 2003 Received: January 31, 2003
Dear Ms. Fylling
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of In Vitro Diagnostic Device Evaluation and Safety has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings and Precautions section of the device's labeling:
The safety and effectiveness of this device for in vivo indications for use has not been established.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
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Page 2 - Mr. Lonnie Witham
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).
If you desire specific information about the application of other labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
& Duton
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE B.
Applicant: Cytomedix, Inc. 510(k) Number (if known): K030340 Device Name: AutoloGel Process Centrifuge Indications For Use:
The AutoloGel Process Centrifuge is designed to be used at the patient's point of care for the safe and rapid preparation of platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Jacchini Santini
মুক্
1
Prescription Use (per 21 CFR 801.109)
I Laboratory Devices
510(k) Number K030340
Over-the Counter Use
(Per 21 CFR 801.109) (Optional Format 1-2-96)
January 31, 2003 CYTOMEDIX, INC. X AutoloGel Process Centrifuge
§ 862.2050 General purpose laboratory equipment labeled or promoted for a specific medical use.
(a)
Identification. General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.(b)
Classification. Class I (general controls). The device is identified in paragraph (a) of this section and is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.