(90 days)
Not Found
Not Found
No
The summary describes a simple aspiration pump with adjustable suction, with no mention of AI, ML, image processing, or data analysis capabilities.
No
The device is an aspiration pump used during surgical procedures to remove fluid and tissue. It does not provide any therapeutic effect to the patient.
No
The device is described as an aspiration pump used to remove fluid and tissue from a surgical site, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is an aspiration pump with user adjustable aspiration suction underpressure, which is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures." This describes a surgical tool used during a procedure on a patient, not a device used to test samples outside the body to diagnose or monitor a condition.
- Device Description: The description confirms it's an "aspiration pump with user adjustable aspiration suction underpressure." This is consistent with a surgical suction device.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) for diagnostic purposes. The device's function is purely mechanical – to remove fluid and tissue from the surgical site.
Therefore, this device falls under the category of a surgical instrument, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.
ContraIndications for Use: These instruments are contraindicated for liposuction procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The Karl Storz Unimat 45 and accessories are a aspiration pump with user adjustable aspiration suction underpressure.
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
qualified surgeons
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.
Not Found
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
Image /page/0/Picture/0 description: The image shows the logo for Karl Storz Endoscopy. The logo is white and the background is black. The logo is made up of the words "STORZ" and "Karl Storz Endoscopy".
5981723
AUG 12 1998
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Kevin Kennan
Senior Regulatory Affairs Specialist |
| Device Identification: | Common Name:
Suction Pump |
Trade Name: (optional) Karl Storz Unimat 45
The Karl Storz Unimat 45 system is designed to provide aspiration of the surgical site Indication: during laparoscopic and aesthetic surgical procedures.
Device Description: The Karl Storz Unimat 45 and accessories are a aspiration pump with user adjustable aspiration suction underpressure.
The Karl Storz Unimat 45 system is substantially equivalent to the Substantial Equivalence: predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Unimat 45 and the predicate devices raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or intended use of these devices.
Signed:
:
Kevin Kennan
Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines representing the wings and two curved lines representing the body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 2 1998
Mr. Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy-America, Inc. 600 Corporate Pointe Culver City, California 90230-7600
K981703 Re: Trade Name: KSEA Unimat 45 Regulatory Class: II Product Code: GCJ Dated: July 23, 1998 Received: July 24, 1998
Dear Mr. Kennan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Mr. Kennan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Hunell Payne
on Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): K981703
Device Name: Unimat 45
Indications for Use: These instruments are intended for use by qualified surgeons and provide aspiration of fluid and tissue from the surgical site during laparoscopic surgical procedures, and general and endoscopic plastic, reconstructive and aesthetic surgical procedures.
ContraIndications for Use: These instruments are contraindicated for liposuction procedures.
(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 General Restorative Devices | |
| 510(k) Number | K981703 |
| Prescription Use:
(Per 21 CFR 801.109) | X | OR Over-The-Counter Use:
(Optional Format 1-2-96) |
| ------------------------------------------- | --- | ------------------------------------------------------ |
|---|