(55 days)
Not Found
Not Found
No
The description focuses on the mechanical function of a centrifuge and does not mention any computational or algorithmic processes indicative of AI/ML.
No
The device is described as preparing platelet-poor plasma and platelet concentrate for diagnostic tests, not for direct therapeutic application to a patient.
No
The device prepares samples (platelet poor plasma and platelet concentrate) that can then be used for diagnostic tests; the device itself does not perform diagnostic tests.
No
The device description explicitly states it consists of a table-top centrifuge and a single-use processing disposable, indicating it is a hardware-based system with physical components.
Based on the provided information, the 3i "CelSep" Centrifuge System is not an IVD (In Vitro Diagnostic) device itself.
Here's why:
- The device's primary function is to prepare samples (plasma and platelet concentrate) from whole blood. It is a tool used in the process of preparing samples for diagnostic testing.
- The intended use states that the prepared plasma and concentrated platelets can be used for diagnostic tests. This indicates that the diagnostic testing is a separate step performed after the sample preparation by the CelSep system.
- An IVD device is typically a reagent, instrument, or system intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The CelSep system doesn't perform the diagnostic test itself; it prepares the sample for such tests.
Think of it like this: A centrifuge is a piece of laboratory equipment. While it's essential for preparing samples for many IVD tests, the centrifuge itself isn't the diagnostic test.
Therefore, the 3i "CelSep" Centrifuge System is a laboratory instrument used in the preparation of samples for IVD testing, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The 3i "CelSep" centrifuge System is designed 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 of blood. The 3i "CelSep" Centrifuge System, is designed for use in the clinical laboratory or intraoperatively at point-of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60ml) of whole blood. The plasma and concentrated platelets produced can be used for diagnostic tests.
Product codes (comma separated list FDA assigned to the subject device)
JQC
Device Description
"CelSep" Centrifuge System consists of a table-top, non self-decanting, swinging bucket centrifuge and single-use processing disposable, designed to permit rapid and completely self-contained and safe separation of plasma and platelets from a small volume of whole blood. The centrifuge spins at a maximum speed of 3400 rpms at a maximum force of approximately 2050g.
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
clinical laboratory or intraoperatively at 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): 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.
Not Found
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
§ 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.
0
.
510(k) SUMMARY 3i CelSep Centrifuge System
| Submitter's name and address: | Implant Innovations, Inc.
4555 Riverside Drive
Palm Beach Gardens, FL 33410 | |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Telephone: | (561) 776-6819 | |
| Contact Person: | William G. Conety | |
| Date Summary prepared: | 1999 November 02 | |
| Device proprietary/trade name: | "CelSep" Centrifuge System | |
| Common name: | General Purpose Centrifuge for Clinical Use | |
| Classification Name: | General purpose laboratory equipment labeled or
promoted for a specific medical use (21 CFR
862.2050) | |
| Substantial Equivalence: | The proposed device is substantially equivalent to
other table-top centrifuges previously cleared by the
FDA via the 510(k) Notification process. | |
| Device Description: | "CelSep" Centrifuge System consists of a table-top,
non self-decanting, swinging bucket centrifuge and
single-use processing disposable, designed to permit
rapid and completely self-contained and safe
separation of plasma and platelets from a small
volume of whole blood. The centrifuge spins at a
maximum speed of 3400 rpms at a maximum force
of approximately 2050g. | |
| Intended Use: | The 3i "CelSep" centrifuge System is designed 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 of blood. | |
| Technological Characteristics: | "CelSep" centrifuge has the same technological
characteristics and is similar in design and
configuration compared with the predicate device
(See Table 15c) | |
| Principle of operation | Separation based on density
processing speed and equipment | Separation based on density
processing speed and equipment |
| Table-Top Design | Yes | Yes |
| Refrigerated | No | No |
| Swinging Bucket | Yes | Yes |
| Automatic Decanting | No (1) | Yes |
| Micro-Processor Controlled | Yes | Yes |
| User Programmable | Yes | No |
| Speed Control | Selectable | Preset |
| Acceleration/breaking | Current-controlled | Current-controlled |
| Maximum RPM | 3400 RPM | 6000g |
| Maximum RCF | 2050 RPM | 3550g |
| Processing capacity | 1 disposable
60ml/disposable | 2 disposables
50ml/disposable |
| Lid Locking/Holding | Yes | Yes |
| Imbalance Detector | No (2) | Yes |
| Construction | Anti-rotational, metal
housing and rotor | Anti-rotational, metal
housing and rotor |
1
Table 15a
COMPARISON OF 3i "CelSep" AND PREDICATE CENTRIFUGE
Features
3i "CelSep"
Predicate Centrifuge
- (1) The "CelSep" centrifuge is not automatic decanting by design. The processing disposable is completely self-contained and is manually, pneumatically decanting.
- (2) No imbalance detection feature is required by "CelSep" due in part to the lower speeds required for processing.
2
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 stripes forming its body and wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
1 2000 FEB
Mr. William G. Conety Regulatory Affairs Implant Innovations, Inc. 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K994148
Trade Name: 3i "CelSep" Centrifuge System Regulatory Class: I Product Code: JQC Dated: December 1, 1999 Received: December 8, 1999
Dear Mr. Conety:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number: K 994/48
Page 1 of 1
3i "CelSep" Centrifuge System Device Name:
INDICATIONS FOR USE:
The 3i "CelSep" Centrifuge System, is designed for use in the clinical laboratory or intraoperatively at point-of care, for the safe and effective preparation of platelet poor plasma and platelet concentrate from a small sample (50-60ml) of whole blood.
The plasma and concentrated platelets produced can be used for diagnostic tests.
DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Rita E. Madini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K994148
Prescription Use: √
(Per 21 CFR 801.109)
OR
Over the counter use: ________________________________________________________________________________________________________________________________________________________