(71 days)
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.
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.
This 510(k) premarket notification for the Maquet GmbH & Co. KG MEDAP BORA device does not contain information about specific acceptance criteria, device performance results, or a study design in the way one would typically find for an AI/ML-driven medical device. Instead, it describes a traditional medical device (a powered suction pump) and focuses on establishing substantial equivalence to a predicate device.
Therefore, many of the requested categories are not applicable to the provided document. I will fill in the available information and explicitly state when information is not present or not relevant for this type of submission.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated in terms of quantitative metrics for performance as an AI/ML device) | Reported Device Performance (Summary of equivalence) |
|---|---|
| Substantial equivalence to predicate device (Vacuson 40, K042943) in: | "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.""The BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting incorporate similar fundamental scientific technology as its predicate device.""The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting are equivalent to the predicate device." |
| - Intended Use | - Intended use is presented as equivalent (as extraction suction units for aspiration and removal of fluids and infectious material). |
| - Principles of Operation | - Operates as a high-performance, low-noise suction pump with an electrically driven unit, overflow protection, and bacterial/viral filters, similar to the predicate. |
| - Design | - Design is presented as equivalent to the predicate. |
| - Physical Characteristics | - Physical characteristics are presented as equivalent to the predicate. |
| - Performance (e.g., vacuum range, flow rate, safety features) | - Vacuum can be set from 0 to -90kPa (0 to -675 mmHg). Performance data stated as equivalent to the predicate device. Specific quantitative performance metrics beyond vacuum range are not detailed in this summary. Product features like overflow protection, hydrophobic bacterial/viral filters, and bacterial filter paper for exhaust air are mentioned as safety features. |
| - Safety | - Safety features (overflow protection, bacterial/viral filters) are described, and overall safety is presented as equivalent to the predicate. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This document describes a traditional medical device (powered suction pump) and does not involve AI/ML technology. Therefore, there is no "test set" in the context of evaluating an algorithm's performance on data. The evaluation is based on engineering principles, design specifications, and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This is not an AI/ML device requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not an AI/ML device requiring data adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for this device would be its ability to meet engineering specifications (e.g., vacuum pressure, flow rates, safety mechanisms) which are established through bench testing and compliance with relevant standards, rather than clinical ground truth as understood for AI/ML.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
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1092903
Maquet GmbH & Co. KG
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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. |
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510(k) SUMMARY (continued)
| Indications for Use | The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING areintended as extraction suction units for aspiration and removal of fluids, andinfectious material from wounds or tissue either during surgery or at the patient'sbedside. |
|---|---|
| Technologicalcharacteristics | The BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting incorporatesimilar fundamental scientific technology as its predicate device. |
| Performancedata | The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080Mounting are equivalent to the predicate device. |
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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 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
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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 areintended as extraction suction units for aspiration and removal of fluids, andinfectious material from wounds or tissue either during surgery or at the patient'sbedside. |
| 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
§ 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.