Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of a centrifuge for separating blood components and does not mention any AI or ML capabilities.

Therapeutic

No.
The device is a centrifuge used to prepare platelet-rich plasma, which is then used as a therapeutic agent. The device itself is not directly therapeutic; it prepares a substance for therapeutic use.

Diagnostic

No
Explanation: The device is used for the preparation of platelet-rich plasma (PRP) from a patient's blood sample. This is a processing function, not a diagnostic one that identifies a disease or condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a "table-top, non self-decanting, rotor spin centrifuge and processing disposables," which are hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to prepare platelet-rich plasma (PRP) from a patient's blood sample. This is a sample preparation step, not a diagnostic test performed on the sample to determine a disease or condition.
Device Description: The device is a centrifuge designed to separate blood components. It does not perform any analysis or measurement of analytes within the blood.
Lack of Diagnostic Information: There is no mention of the device being used to detect, diagnose, monitor, or predict any disease or condition.

IVD devices are typically used to perform tests on biological samples (like blood, urine, tissue) to provide information for diagnostic purposes. This device's function is solely to process the blood sample for subsequent use, likely in a therapeutic or regenerative medicine context, rather than for diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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 autologous platelet-rich plasma (PRP) from a small sample of the patient's blood (up to 60 ml).

Product codes

JQC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

patient's point of care

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)

K991430, K994148

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Original 510(k) Notification

……………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………………

CONFIDENTIAL

D. 510(K) SUMMARY

KO 30340

APR 11 2003

510K Summary for the AutoloGel Process Centrifuge

| Submitter's Name and Address: | Cytomedix, Inc
1523 S. Bowman Road, Suite A
Little Rock, AR 72211 |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Phone Number: | 501-219-2111 |
| Fax Number: | 501-219-2114 |
| Contact Person: | Carelyn P. Fylling
Vice President of Professional Services
218-547-4142 (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 promoted
for 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 other
table-top centrifuges previously cleared by the FDA via the
510K Notification process. Two predicative centrifuges have
been identified: Harvest Technologies, LLC., SmartPrep
Centrifugation System (K991430) and 3i Models 7426 and
7437 CelSep Centrifuge System (K994148). |
| Device Description: | 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. |
| Intended Use: | The AutoloGel Process Centrifuge is designed to be used at
the patient's point of care for the safe and rapid preparation
of autologous platelet-rich plasma (PRP) from a small sample
of 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	Cytomedix
AutoloGel Process
Centrifuge
(This submission)	Harvest SmartPrep
Centrifuge System
K991430	3i CelSep
K994148
Intended Use	To be used at the
patient's point-of-care
for the safe and rapid
preparation of
autologous platelet-
rich plasma (PRP)
from a small sample
of the patient's blood
(up to 60 ml).	To be used in the
clinical laboratory or
intraoperatively at
point-of-care for the
safe and rapid
preparation of platelet
poor plasma and
platelet concentrate
from a small sample
of blood. The plasma
and concentrated
platelets produced can
be used for diagnostic
tests.	For use in the clinical
laboratory or
intraoperatively at
point-of-care for the
safe and rapid
preparation of platelet
poor plasma and
platelet concentrate
from a small sample
(50 - 60 ml of whole
blood. The plasma
and concentrated
platelets produced can
be used for diagnostic
tests.
Principles of
Operation	Separation based on
density of liquids	Separation based on
density of liquids	Separation based on
density 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-Processor
Controlled	Yes	Yes	Yes
User Programmable	No, preset by
manufacturer	No, preset by
manufacturer	Yes
Speed Control	Preset	Preset	Selectable
Acceleration and
Braking	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 Processing
Disposables (50 ml
/disposable)	1 Disposable
60 ml/disposable
Lid Locking, Lid
Holding	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

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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