(128 days)
Not Found
No
The description focuses on a mechanical, disposable system for blood collection and reinfusion, with no mention of AI/ML terms or functionalities.
Yes.
The device is intended for the reinfusion of autologous blood, which is a therapeutic intervention.
No
Explanation: The device is intended for the collection, filtration, and reinfusion of autologous blood post-operation. It is a therapy delivery system, not a diagnostic one.
No
The device description clearly outlines multiple physical components (wound drain, trocars, blood lines, reservoir, evacuator, etc.), indicating it is a hardware-based medical device.
Based on the provided information, the HEMOVAC® Blood Reinfusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the "post operative collection, filtration, and reinfusion of autologous blood." This describes a process performed on blood outside the body for therapeutic purposes (reinfusion), not for diagnostic testing or analysis of the blood itself.
- Device Description: The components listed (wound drain, blood lines, reservoir, evacuator, etc.) are all related to the physical collection, processing (filtration), and delivery of blood. There are no components or descriptions related to analyzing or testing the blood for diagnostic information.
- Lack of Diagnostic Elements: There is no mention of any features or functions that would involve analyzing blood components, detecting markers, or providing diagnostic information about the patient's condition.
- Performance Studies: The performance studies mentioned focus on standards related to autologous transfusion devices and biological evaluation, not on the accuracy or performance of diagnostic tests.
IVD devices are specifically designed to perform tests on specimens (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The HEMOVAC® system's purpose is to collect and reinfuse blood, which is a therapeutic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.
Product codes
CAC
Device Description
The HEMOVAC® Blood Reinfusion System is a sterile, single patient use, closed, disposable system intended for post operative collection, filtration, and reinfusion of autologous blood. The system consists of a wound drain and trocars, blood lines, graduated 800ml blood collection reservoir (contains pre-filter, air filter, fat retention valve), Hemovac® evacuator, anticoagulant port, transfer tube, and blood reinfusion bag.
The wound is drained utilizing suction created by activating the Hemovac® evacuator. Blood passes through the drain, blood line tubing, and into the collection reservoir (pre-filter located inside of collection reservoir).
Anticoagulant may be added through the injection port located in the blood line. Anticoagulant therapy is administered at the discretion of the physician.
To reinfuse the collected blood back to the patient. the blood is transferred from the collection reservoir to the reinfusion bag via gravity feed. A fat retention valve (located inside of the collection reservoir) is designed to retain the top portion of the collected blood which may contain fats. The blood bag is spiked with a standard patient administration set that contains a 20-40 micron filter (not supplied with the system), and the blood bag is gravity reinfused to the patient per hospital/AABB guidelines.
The process is repeated for additional collection/reinfusions. After collection for reinfusion is no longer desired, the system can be converted to straight drainage for disposal only. The Hemovac® evacuator is removed from the collection reservoir and reconnected to the blood line assembly. An accessory infection control bag (not supplied with the system) may be used to empty the contents of the evacuator. This is used for disposal only.
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
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
Non-Clinical Performance and Conclusions: This device has been tested and does meet the applicable sections of the American National Standard for Autologous Transfusion Devices, ANSI/AAMI AT6-1991, as well as ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices." Hemocompatibility was conducted in accordance with AAMI/ANSI/ ISO 10993-4:2002.
Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device.
Key Metrics
Not Found
Predicate Device(s)
K920273, K952224, K913247 or 914119
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5830 Autotransfusion apparatus.
(a)
Identification. An autotransfusion apparatus is a device used to collect and reinfuse the blood lost by a patient due to surgery or trauma.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo for Zimmel. The logo consists of a stylized letter Z inside of a circle. To the right of the circle is the word "zimmel" in lowercase letters.
Summary of Safety and Effectiveness
| Submitter: | Zimmer Orthopaedic Surgical Products
200 West Ohio Avenue
P.O. Box 10
Dover, Ohio 44622 |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Cindy J. Dickey
Regulatory Compliance Manager
Telephone: (330) 364-9493
Fax: (330) 364-9490 |
| Date: | June 4, 2004 |
| Trade Name: | HEMOVAC® BLOOD REINFUSION SYSTEM |
| Common Name: | Autotransfusion System |
| Classification Name
and Reference: | Apparatus, Autotransfusion
21 CFR § 868.5830 |
| Predicate Devices: | Zimmer Hemovac® Autotransfusion System,
manufactured by Zimmer Orthopaedic Surgical
Products, K920273, cleared January 28, 1993 |
| | CBC II Constavac™ Autotransfusion System,
manufactured by Stryker®, K952224, cleared
November 17, 1995 |
| | Suretrans™ Autotransfusion System, manufactured
by Davol®, K913247 or 914119, cleared February
25, 1993 or December 3, 1992 |
| Device Description: | The HEMOVAC® Blood Reinfusion System is a
sterile, single patient use, closed, disposable system
intended for post operative collection, filtration, and
reinfusion of autologous blood. |
| | The system consists of a wound drain and trocars,
blood lines, graduated 800ml blood collection
reservoir (contains pre-filter, air filter, fat retention
valve), Hemovac® evacuator, anticoagulant port,
transfer tube, and blood reinfusion bag. |
1
The wound is drained utilizing suction created by activating the Hemovac® evacuator. Blood passes through the drain, blood line tubing, and into the collection reservoir (pre-filter located inside of collection reservoir).
Anticoagulant may be added through the injection port located in the blood line. Anticoagulant therapy is administered at the discretion of the physician.
To reinfuse the collected blood back to the patient. the blood is transferred from the collection reservoir to the reinfusion bag via gravity feed. A fat retention valve (located inside of the collection reservoir) is designed to retain the top portion of the collected blood which may contain fats. The blood bag is spiked with a standard patient administration set that contains a 20-40 micron filter (not supplied with the system), and the blood bag is gravity reinfused to the patient per hospital/AABB guidelines.
The process is repeated for additional collection/reinfusions. After collection for reinfusion is no longer desired, the system can be converted to straight drainage for disposal only. The Hemovac® evacuator is removed from the collection reservoir and reconnected to the blood line assembly. An accessory infection control bag (not supplied with the system) may be used to empty the contents of the evacuator. This is used for disposal only.
Indications for Use: The Hemovac® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.
Comparison to Predicate Device:
The Hemovac® Blood Reinfusion system is substantially equivalent to the legally marketed
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Image /page/2/Picture/0 description: The image contains the logo for Zimmer Biomet. The logo consists of a circle with a stylized letter "Z" inside, followed by the word "zimmer" in a bold, sans-serif font. The logo is black and white.
autotransfusion systems, specifically the Stryker® CBC II Constavac™, Davol® Suretrans™, and the Zimmer Hemovac® Autotransfusion in that the devices are similar in design, materials, and indications for use.
Performance Data (Nonclinical and/or Clinical):
Non-Clinical Performance and Conclusions:
This device has been tested and does meet the applicable sections of the American National Standard for Autologous Transfusion Devices, ANSI/AAMI AT6-1991, as well as ANSI/AAMI/ ISO 10993-1:1997, "Biological evaluation of Medical Devices." Hemocompatibility was conducted in accordance with AAMI/ANSI/ ISO 10993-4:2002.
Clinical Performance and Conclusions:
Clinical data and conclusions were not needed for this device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three flowing lines representing the body.
Public Health Service
OCT 1 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Zimmer Orthopaedic Surgical Products c/o Ms. Cindy J. Dickey Regulatory Compliance Manager 200 West Ohio Avenue P.O. Box 10 Dover, OH 44622
Re: K041525
Trade/Device Name: Hemovac® Blood Reinfusion System Regulation Number: 21 CFR 868.5830 Regulation Name: Autotransfusion apparatus Regulatory Class: II Product Code: CAC Dated: June 4, 2004 Received: September 22, 2004
Dear Ms. Dickey:
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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. 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 Part 801); good manufacturing practice requirements as set
4
Page 2 – Ms. Cindy J. Dickey
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality by oversions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation only to begin marketing your device as described in your Section 510(k) rins letter with anon yourse FDA finding of substantial equivalence of your device to a legally prematic. In a classification of 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), please 11 you dome office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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,
Dmna R. boihner
- J Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): KO4 | 5 25
Device Name:
Hemovac® Blood Reinfusion System
Indications for Use:
The HEMOVAC® Blood Reinfusion System is a closed system intended for post operative collection, filtration, and reinfusion of autologous blood. It is the responsibility of the physician to determine if this therapy is appropriate for a specific procedure.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vochner
(Division Sign-Off) Division of Cardiovascular Devices
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510(k) Number K041525