(71 days)
Not Found
No
The device description focuses on mechanical and electrical components for suction and fluid management, with no mention of AI or ML terms or functionalities.
No
The device is described as an extraction suction unit for removing fluids and infectious material, which is a supportive rather than a therapeutic function.
No
The device is described as an "extraction suction unit for aspiration and removal of fluids, and infectious material from wounds or tissue," which is a therapeutic function, not a diagnostic one. It removes substances from the body rather than analyzing them to determine a medical condition.
No
The device description clearly details a physical suction pump with electrical components, filters, and a vacuum gauge, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the aspiration and removal of fluids and infectious material from wounds or tissue during surgery or at the patient's bedside. This is a direct interaction with the patient's body for therapeutic or procedural purposes.
- Device Description: The description details a suction pump designed to create vacuum for removing fluids. It focuses on the mechanical function of the device.
- Lack of IVD Characteristics: An IVD device is used to examine specimens from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any analysis or testing of specimens. It is a tool for removing material from the body.
The device described is a surgical suction unit, which is a medical device used in a clinical setting, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.
Product codes (comma separated list FDA assigned to the subject device)
BTA
Device Description
The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting are equivalent to the predicate device.
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
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.
0
1092903
Maquet GmbH & Co. KG
ﺮ = '
510(k) Premarket Notification MEDAP BORA
DEC - 1 2009 APPENDIX A. 510(K) SUMMARY
| 510(k) SUMMARY | |
|---|---|
| Submitter | Maquet GmbH & Co. KG |
| Submitter's Address | Kehler Strasse 31 |
| 76437 Rastatt | |
| Germany | |
| Telephone | +49 (0) 7222 932-229 |
| Fax | +49 (0) 7222 932-634 |
| a.jakob@maquet.de | |
| Contact Person | Annette Jakob, Regulatory Affairs |
| Date Prepared | July 29, 2009 |
| Device Trade Name | BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting |
| Device Common Name | Powered Suction Pump |
| Device Classification Name | General Surgery |
| Device Classification | Class II |
| Summary of substantial equivalence | The intended use, principles of operation, design, physical characteristics, performance and safety of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting are substantially equivalent to Vacuson 40 cleared by the Food and Drug Administration under K042943 on Dec 17, 2004. |
| Device description | The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge. |
Image /page/0/Picture/5 description: The image shows a black and white silhouette of a person's head and shoulder. The person appears to be facing to the right. The image is simple and lacks detail, focusing on the outline of the figure.
1
510(k) SUMMARY (continued)
| Indications for Use | The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are
intended as extraction suction units for aspiration and removal of fluids, and
infectious material from wounds or tissue either during surgery or at the patient's
bedside. |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological
characteristics | The BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting incorporate
similar fundamental scientific technology as its predicate device. |
| Performance
data | The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080
Mounting are equivalent to the predicate device. |
——————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————————
Image /page/1/Picture/4 description: The image contains a small, abstract symbol. The symbol appears to be composed of curved lines, possibly resembling a stylized letter or character. The image is simple and lacks any background or additional details.
2
Image /page/2/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 resembling a stylized caduceus or a representation of human figures.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
Maquet GmbH and Co. KG % TÜV SÜD America, Inc. Mr. Stefan Preiss 1775 Old Highway 8 NW New Brighton, Minnesota 55112-1891
DEC - 1 2009
Re: K092903
Trade/Device Name: BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 MOUNTING Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: BTA Dated: November 13, 2009 Received: November 18, 2009
Dear Mr. Preiss:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
3
Page 2 - Mr. Stefan Preiss
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director · Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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APPENDIX E. INDICATIONS FOR USE STATEMENT
| 510(k) number
| (if known) | The 510(k) number has not been issued yet. |
|---|---|
| Device name | BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 MOUNTING |
| Indications for Use | The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are |
| intended as extraction suction units for aspiration and removal of fluids, and | |
| infectious material from wounds or tissue either during surgery or at the patient's | |
| bedside. | |
| Prescription Use | |
| (21 CFR 801 Subpart D) | X |
OR
| Over-The-Counter Use
| (21 CFR 801 Subpart C) | |
|---|---|
| ------------------------------------------------ | -- |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Surgical, Orthopedic, |
- Division of Surgical, and Restorative Devices
510(k) Number K892903