(67 days)
Not Found
No
The document describes a mechanical system for blood collection and chest drainage and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for purposes like evacuating fluid, preventing reaccumulation, re-establishing normal pressure, and facilitating lung re-expansion, all of which directly address and improve a patient's medical condition.
No
The device is described as an autotransfusion and chest drainage system, designed for collecting and reinfusing blood or evacuating fluids/air. Its intended use focuses on therapeutic and supportive functions (collection, reinfusion, drainage, prevention of reaccumulation, re-establishment of pressure gradients, facilitating lung re-expansion) rather than identifying or analyzing a disease or condition.
No
The device description explicitly states it is a "multi-chamber collection/reinfusion system" and "sterile, single use devices," indicating it is a physical hardware system for collecting and reinfusing blood and draining the chest.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function as a system for collecting and reinfusing blood from the chest cavity and for chest drainage. These are procedures performed directly on the patient's body, not on samples of bodily fluids or tissues in vitro (outside the body) for diagnostic purposes.
- Device Description: The description reinforces its function as a collection/reinfusion and chest drainage unit, again focusing on direct interaction with the patient's body.
- Lack of Diagnostic Activity: There is no mention of analyzing blood or fluid samples, detecting biomarkers, or providing diagnostic information based on the collected material. The focus is on the physical collection and reinfusion process.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function falls outside of that definition.
N/A
Intended Use / Indications for Use
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use:
AUTOTRANSFUSION
- for the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations
CHEST DRAINAGE
-
- to evacuate air and/or fluid from the chest cavity or mediastrinum
-
- to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum
-
- to help re-establish and maintain normal intrathoracic pressure gradients
-
- to facilitate complete lung re-expansion to restore normal breathing dynamic.
Product codes (comma separated list FDA assigned to the subject device)
CAC
Device Description
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a multi-chamber collection/reinfusion system. The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a sterile, single use devices intended for the collection of autologous blood (autotransfusion) and as chest drainage collection units.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pleural cavity or mediastinal area, chest cavity or mediastinum
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 (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.
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
§ 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).
0
JUL 2 5 2003
Section X 510 (K) Summary of Substantial Equivalence
In accordance with the requirements of 21 CFR § 807, this summary is formatted with the Agency's final rule "....510(k) Summaries and 510(k) Statements ...." and can be used to provide equivalence summary to anyone requesting it from the Agency.
| Date Prepared: | March 24, 2003 |
|---|---|
| Manufacturer | Genzyme Biosurgery |
| A division of GENZYME CORPORATION | |
| 600 Airport Road | |
| Fall River, MA 02720 | |
| Contact Person | Denise Lima |
| Phone: (508) 677-6439 | |
| Fax: (508) 677-6667 | |
| e-mail: denise.lima@genzyme.com | |
| Device Information | |
| Trade Name: | Pleur-evac® Sahara Plus Continuous |
| Reinfusion Autotransfusion System | |
| Common Name: | Continuous Reinfusion Autotransfusion System |
| Classification Name: | Autotransfusion Apparatus |
| (per 21 CFR § 868.5830) |
Indications for Use
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use:
AUTOTRANSFUSION
- for the collection of autologous blood from the patient's pleural cavity or mediastinal area for reinfusion purposes in trauma and post operative situations
CHEST DRAINAGE
-
- to evacuate air and/or fluid from the chest cavity or mediastrinum
-
- to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum
-
- to help re-establish and maintain normal intrathoracic pressure gradients
-
- to facilitate complete lung re-expansion to restore normal breathing dynamic.
1
Device Description
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a multi-chamber collection/reinfusion system. The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is a sterile, single use devices intended for the collection of autologous blood (autotransfusion) and as chest drainage collection units.
Substantial Equivalence
The Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System of this submission is similar in intended use, materials and performance characteristics of the currently marketed Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System (#K963850).
The determination of substantial equivalence for this device was based on a detailed device description, performance testing and conformance with consensus and voluntary performance standards.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2003
Genzyme Biosurgery c/o Ms. Denise Lima 600 Airport Road Fall River, MA 02720
Re: K031554
Pleur-evac® Sahara Plus Continuous Reinfusion Autotransfusion System Regulation Number: 868.5830 Regulation Name: Autotransfusion Apparatus Regulatory Class: Class II (two) Product Code: CAC Dated: May 16, 2003 Received: May 19, 2003
Dear Ms. Lima:
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. Iisting 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.
3
Page 2 - Ms. Denise Lima
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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. 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.
KQaGTU
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known) Device Name
Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System
Section II Indications for Use
Pleur-evac Sahara Plus Continuous Reinfusion Autotransfusion System is indicated for use:
AUTOTRANSFUSION
- for the collection of autologous blood from the patient's pleural cavity or 1) mediastinal area for reinfusion purposes in trauma and post operative situations.
CHEST DRAINAGE
- to evacuate air and/or fluid from the chest cavity or mediastinum 2)
- to help prevent air and/or fluid from re-accumulating in the chest cavity or 3) mediastinum
- to help re-establish and maintain normal intrathoracic pressure gradients, 4) and to facilitate complete lung re-expansion to restore normal breathing dynamics.
Voeertu
510(k) Number K031554
Prescription Use
(Per 21 CFR § 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)