(15 days)
Not Found
No
The summary describes a standard suction pump system and does not mention any AI or ML capabilities, image processing, or data sets typically associated with AI/ML devices.
Yes
The device is described as promoting wound healing and removing fluids from wounds, which aligns with the definition of a therapeutic device.
No
The device is described as applying suction to wounds to promote healing and remove fluids, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly states it consists of a "powered suction pump" and "disposables," indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for applying suction to wounds to promote healing and remove fluids. This is a therapeutic and fluid management function performed directly on the patient's body.
- Device Description: The description details a powered suction pump and associated disposables for fluid collection and wound contact. This aligns with a medical device used for treatment and fluid removal, not for analyzing samples in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status. IVDs are designed to perform tests on these types of samples.
Therefore, the Boehringer Laboratories Suction Pump System is a medical device used for wound care and fluid management, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.
Product codes (comma separated list FDA assigned to the subject device)
JCX, OMP
Device Description
The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of suction to wounds and for fluid removal. Disposables for use with the pump include: canister, Tube Attachment Device, Cover and Wound Contact Dressing
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)
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
§ 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
2. 510(k) Summary
510(k) Summary
Applicant Information:
- Name: Boehringer Laboratories Inc.
- 500 E. Washington St. Address: Norristown PA 19401
Phone: 610-278-0900 Fax: 610-278-0907
- Contact: Christopher Radl, Engineering
Trade Name:
Boehringer Laboratories Suction Pump System
Common Name:
Powered Suction Pump
Device Classification:
Class II Product Code: JCX Regulation 878.4780 Classification Panel: General & Plastic Surgery
Predicate Devices:
Boehringer Laboratories Suction Pump System Versatile 1 Wound Vacuum System
Device Description:
The Boehringer Laboratories Suction Pump System consists of a powered suction pump for the application of suction to wounds and for fluid removal. Disposables for use with the pump include: canister, Tube Attachment Device, Cover and Wound Contact Dressing
Intended Use:
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.
1
Technological Characteristics:
The modified Boehringer Laboratories Suction Pump System includes the same suction pump and canister as the predicate unmodified device K060277. Additional accessories have been added. These accessories are a Wound Cover, Tube Attachment Device and Wound Contact Dressing. These accessories correspond with accessories available with the predicate Versatile 1 System K042134, K052456. The labeling and indications for use statement have been revised to more specifically cover application of suction to wounds, similar to the predicate Versatile 1 System K042134, K052456,
Conclusion:
The Boehringer Laboratories Suction Pump System is substantially equivalent to the predicate devices.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design that resembles an eagle or a bird in flight. The emblem is rendered in black and white.
Public Health Service
APR - 7 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boehringer Laboratories % Mr. John R. Boehringer 500 E. Washington Street Norristown, Pennsylvania 19401
Re: K061788
Trade/Device Name: Boehringer Laboratories Suction Pump System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered Suction Pump Regulatory Class: II Product Code: OMP Dated: June 22, 2006 Received: June 26, 2006
Dear Mr. Boehringer:
This letter corrects our substantially equivalent letter of July 11, 2006.
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 (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 vour 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
3
Page 2 - Mr. John R. Boehringer
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 (OS) 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 continue 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 (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
For. Peterson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): KO61789
Device Name: Boehringer Laboratories Suction Pump System
Indications for Use:
The Boehringer Laboratories Suction Pump System is intended for the application of suction (negative pressure) to wounds to promote wound healing and for the removal of fluids, including wound exudate, irrigation fluids, body fluids and infectious materials.
Prescription Use × (Part 21 CFR 801 Subpart D)
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AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hester Lemur
(Driver Sign Off)
eral, Restorative. Division of Ger and Neurological Devices
510(k) Number K061788