(204 days)
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Not Found
No
The summary describes a low-pressure infusion pump and pressure chambers for irrigation, with no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is used for irrigation during surgery, which is a procedural aid rather than a therapeutic treatment itself. It facilitates the surgical procedure but does not directly treat a disease or condition.
No
The device is used for irrigation during diagnostic and surgical procedures, but it does not perform the diagnostic function itself. It facilitates fluid delivery during diagnostic procedures rather than generating diagnostic information.
No
The device description clearly outlines hardware components: a low-pressure infusion pump (KSEA Hydromat 263110-20), metal pressure chambers, and tubing sets. This indicates it is a hardware-based medical 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 clearly states the device is for providing irrigation to the peritoneal cavity and operative sites during surgical and diagnostic procedures. This is an in vivo application (within the living body).
- Device Description: The description reinforces this by explaining it's a pump and chambers for delivering sterile irrigating fluid to the operative site.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed for testing samples in vitro (in a test tube or laboratory setting). This device is used directly on or within the patient during a procedure.
N/A
Intended Use / Indications for Use
The KSEA Hydromat 263110-20 and Pressure Chambers are, indicated for use by qualified surgeons and physicians to provide low-pressure irrigation to the peritoneal cavity and operative sites during laparoscopic and pelviscopic surgical and diagnostic procedures.
Product codes (comma separated list FDA assigned to the subject device)
85 HET
Device Description
The KSEA Hydromat 263110-20 is a low-pressure infusion pump designed to deliver sterile irrigating fluid to the operative site. The KSEA Pressure Chambers are metal chambers designed to hold and pressurize bags of irrigation fluid for infusion into the peritoneal cavity; a pressure chamber is available which heats the irrigation fluid to body temperature or to slightly above body temperature. The Accessories (Tubing Sets) are designed to convey the sterile irrigation solution into the peritoneal cavity.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
peritoneal cavity and operative sites during laparoscopic and pelviscopic surgical and diagnostic procedures.
Indicated Patient Age Range
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Intended User / Care Setting
qualified surgeons and physicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/0 description: The image shows a logo for Karl Storz Endoscopy. The logo features a stylized circle with a smaller circle inside, next to the letters "RZ". Below the logo, the words "Karl Storz Endoscopy" are written in a simple font. The background of the image is a dark color, and the logo and text are white.
Karl Storz Endoscopy-America. Inc
600 Corporate Pointe Culver City, California 90230-7 Phone 310 558 1500
then
I'm going to
be 100 years old
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submutted 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 are accurate and complete to the rest of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy-America, Inc.
600 Corporate Pointe
Culver City, California 90230
(310) 558-1500 |
|------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact: | Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist |
| Device Identification: | Common Name
Irrigation Pump System |
| | Trade Name (optional)
KSEA Hydromat 263110-20, Pressure Chambers and Accessories |
Indication: The KSEA Hydromat 263110-20 and Pressure Chambers are, indicated for use by qualified surgeons and physicians to provide low-pressure irrigation to the peritoneal cavity and operative sites during laparoscopic and pelviscopic surgical and diagnostic procedures.
Device Description: The KSEA Hydromat 263110-20 is a low-pressure infusion pump designed to deliver sterile irrigating fluid to the operative site. The KSEA Pressure Chambers are metal chambers designed to hold and pressurize bags of irrigation fluid for infusion into the peritoneal cavity; a pressure chamber is available which heats the irrigation fluid to body temperature or to slightly above body temperature. The Accessories (Tubing Sets) are designed to convey the sterile irrigation solution into the peritoneal cavity.
Substantial Equivalence: The KSEA Hydromat 263110-20 and Pressure Chambers are substantially equivalent to the predicate devices since the basic features and intended uses are similar. The minor differences between the Karl Storz Hydromat 263110-20 and Pressure Chambers 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: Marlena Allen Piercy
Marlena Allen Piercy, Ph.D.
Senior Clinical Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes and wings at the top. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the caduceus. The seal is in black and white and appears to be a scanned or printed image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 22 1998
Kevin Kennan Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe Culver City, CA 90230-7600
Re: K972488
KSEA Hydromat 263110-20 pressure chambers and accessories Dated: October 23, 1997 Received: October 24, 1997 Regulatory Class: II 21 CFR 884.1720/Procode: 85 HET
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, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 Radiation Control provisions, or other Federal laws or regulations.
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) 594-4613. 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.
h7liau Yhi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): K972488
Device Name: KSEA Hydromat 263110-20; Pressure Chambers and Accessories
Indications for Use: These instruments are indicated for use by qualified surgeons and physicians to provide pressurized fluid, with a heating option, for irrigation to the surgical site or hydro-dissection during laparoscopic surgical and diagnostic procedures.
Contraindications for Use: These instruments are contraindicated for hysteroscopic procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dokir R. Sothling
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number K972488
Prescription Use: (Per 21 CFR 801.109)
OR Over-The-Counter Use:
(Optional Format 1-2-96)