Predicate Devices

K112624, K122619, K042457, K031457, K083707, K072410, K013838

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on pressure-controlled pumping, software-based safety features, and user interface, with no mention of AI or ML algorithms for data analysis, decision-making, or image processing.

Therapeutic

Yes.
The device is used to provide the infusion of fluids and suction during diagnostic and operative endoscopic procedures, including liquid distention of the uterus and sustained liquid irrigation and distention of joint spaces; these are therapeutic interventions.

Diagnostic

No

The device is an irrigation and suction pump used during diagnostic and operative endoscopic procedures to manage fluids, not to diagnose a condition. Its function is primarily supportive in nature.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "multi-functional, pressure- controlled, combined irrigation and suction pump" and mentions hardware components like a "roller pump" and "tubing sets." While it has software control and a touch screen interface, it is fundamentally a hardware device with integrated software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Endomat Select is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use clearly describes the device's function as providing irrigation and suction during various surgical and endoscopic procedures. This involves interacting directly with the patient's body and fluids in vivo (within the living organism).
Device Description: The description reinforces its function as a pump for irrigation and suction, used during surgical interventions.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the living organism) for the purpose of providing information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to analyze samples like blood, urine, tissue, etc., in a laboratory setting to provide diagnostic information. The Endomat Select's function is entirely focused on facilitating surgical procedures within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Endomat Select is intended to:
• provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
• provide liquid distention of the uterus for diagnostic and operative hysteroscopy
• provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery
• provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery
• provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

Product codes (comma separated list FDA assigned to the subject device)

HIG, BTA, LJH, OCX, HRX, GWG, EOB

Device Description

The Endomat Select is a multi-functional, pressure-controlled, combined irrigation and suction pump. It can be used for irrigation and, where appropriate dilation, during Hysteroscopic (HYS), Arthroscopic (ART), Urological (URO) and General Surgical or Laparoscopic (SURG) interventions. The device can be used for suction during Urological (URO) interventions. In addition the device can function in an oscillatory mode (ENT/Neuro) providing a fluid means to maintain lens clarity during use in Transnasal procedures. The device has a modern LCD display with touch screen user interface. The tubing sets are encoded so that they can be identified by the device, which selects the appropriate operating modes based on the tubing set connected. The device can also be connected to other Karl Storz devices using the proprietary Storz Control Bus (SCB) [K994348].

The device protects the patient from overpressure via software means. The software controlled pressure measurement system can stop the actuator (roller pump) should the pressure rise beyond the pre-determined limit and will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

ureter and upper urinary tract, uterus, organs and operating fields, joint or intra-articular spaces, Sinus, transnasal pituitary gland

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)

Non-Clinical Performance Data: The Endomat Select follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidances:
Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-1-8
Software Verification and Validation Testing Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005 Level of Concern: Major
Summative Usability Testing IEC 62366
Performance Testing Hysteroscopic and Laparoscopic Insufflators: Submission Guidance For A 510(K) issued on August 1, 1995 for Product Code HIG Performance tests of pressure controlled irrigation mode
Performance tests of intrauterine pressure

Additional bench testing was performed to ensure the device met its design specifications.
Verification Test:
Performance: Pressure Control - Pass
Performance: Flow Limitation - Pass
Performance: Flow Control - Pass
Performance: Pressure Limitation - Pass
Performance: Suction Control - Pass
Safety: Overpressure Warning (in pressure relevant GYN and URO interventions) - Pass
Safety: Overpressure Warning (in pressure relevant ARTHRO interventions) - Pass
Safety: Overpressure Alarm (in pressure relevant GYN and URO interventions) - Pass
Safety: Pressure Relief (in pressure relevant GYN and URO interventions) - Pass

Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence.

Conclusion: The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed predicate devices.

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.

World of Medicine AQUILEX FLUID CONTROL SYSTEM H112 (K112624), Applied Medical EPIX (K122619), World of Medicine Uro Pro (K042457), Karl Storz Endomat LC (K031457), Atherex Dual Wave Arthroscopy Pump (K083707), Karl Storz ClearVision (K072410), Karl Storz Clear Vision (K013838)

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

Regulation Number and Section

§ 884.1700 Hysteroscopic insufflator.

(a)
Identification. A hysteroscopic insufflator is a device designed to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter fits which only include accessory instruments that are not used to effect intrauterine access, e.g., hysteroscopic introducer sheaths, etc.; and single-use tubing kits used for only intrauterine insufflation. 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.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 31, 2018

Karl Storz SE & Co. KG Nina Dusper Regulatory Affairs Manager Dr.-Karl-Storz-StraBe 34 Tuttlingen, 78532 Germany

Re: K180735

Trade/Device Name: Endomat Select (Model Number: UP210) Regulation Number: 21 CFR§ 884.1700 Regulation Name: Hysteroscopic Insufflator Regulatory Class: II Product Code: HIG. BTA. LJH. OCX. HRX. GWG. EOB Dated: July 30, 2018 Received: August 2, 2018

Dear Nina Dusper:

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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

1

requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Sharon M. Andrews -S

for

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K180735

Device Name

Endomat Select (Model Number: UP210)

Indications for Use (Describe)

Endomat Select is intended to:

· provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures

· provide liquid distention of the uterus for diagnostic and operative hysteroscopy

· provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery

· provide sustained liquid irrigation of joint or intra-articular spaces during all phases of arthroscopic surgery

· provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically assisted transnasal pituitary gland surgery

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

3

Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

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 KARL STORZ`s knowledge.

| Applicant: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen
Baden-Württemberg, GERMANY |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nina Dusper
Regulatory Affairs Manager
+49 (0) 7461 708-8399
+49 (0) 7461 708-105 |
| Date of Preparation: | 1st February 2018 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: Endomat Select (Model Number: UP210)
Common Name: Suction Irrigation Pump |
| Regulation: | 21 CFR 884.1700 (Hysteroscopic Insufflator) |
| Class: | II |
| Product Code: | HIG: Hysteroscopic Insufflator |
| Additional Product Codes: | BTA: Pump, Portable, Aspiration (Manual or Powered)
LJH: System, Irrigation, Urological
OCX: Endoscopic Irrigation/Suction System
HRX: Arthroscope |

4

Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

GWG: Endoscope, neurological
EOB: Nasopharyngoscope (flexible or rigid)
Predicate Device(s):	World of Medicine AQUILEX FLUID CONTROL SYSTEM
H112 (K112624),
Applied Medical EPIX (K122619),
World of Medicine Uro Pro (K042457),
Karl Storz Endomat LC (K031457),
Atherex Dual Wave Arthroscopy Pump (K083707),
Karl Storz ClearVision (K072410),
Karl Storz Clear Vision (K013838)
The above predicates have not been subject to any recall
Device Description:	The Endomat Select is a multi-functional, pressure-
controlled, combined irrigation and suction pump. It can be
used for irrigation and, where appropriate dilation, during
Hysteroscopic (HYS), Arthroscopic (ART), Urological
(URO) and General Surgical or Laparoscopic (SURG)
interventions. The device can be used for suction during
Urological (URO) interventions. In addition the device can
function in an oscillatory mode (ENT/Neuro) providing a
fluid means to maintain lens clarity during use in Transnasal
procedures. The device has a modern LCD display with
touch screen user interface. The tubing sets are encoded so
that they can be identified by the device, which selects the
appropriate operating modes based on the tubing set
connected. The device can also be connected to other Karl
Storz devices using the proprietary Storz Control Bus (SCB)
[K994348].
The device protects the patient from overpressure via
software means. The software controlled pressure
measurement system can stop the actuator (roller pump)
should the pressure rise beyond the pre-determined limit and

5

Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

will immediately reverse the pump roller direction to depressurize the fluid system if required. Additionally the device has high pressure alarms to alert the operating room staff of a high pressure situation. The device also requires positive action from the user to increase pressures above 100mmHg; the user is prompted to confirm their choice on the user interface.

The accessories for this device are provided separately. All of the accessories for use with this device are already marketed in the U.S. and are either Class I, Class II 510(k) exempt or Class II previously cleared devices. The generic tubing sets for use with this device are single use, sterile Class I accessories.

Accessory description	Part number	Marketing Status
Suction bottle, 5 1, sterilizable	20300050	Class II
510(k) Exempt
Cap for suction bottle 20 3000
50, 5 1 sterilizable	20300034	Class II
510(k) Exempt
Metal filter	20300038	Class II
510(k) Exempt
Bottle stand for suction bottle,
5 I	20300032	Class II
510(k) Exempt
Bottle stand holder	20300033	Class II
510(k) Exempt
Suction bottle, 0,5 I, sterilizable	20300051	Class II
510(k) Exempt
Cap, for suction bottle	20300039	Class II
510(k) Exempt
Bottle stand, for suction bottle	20300231	Class II
510(k) Exempt
Control cable	20701070	Class II
K973251
Single pedal footswitch	20014130	Class II
K072410
SCB connecting cord, length 100
cm	20090170	Class II
K994348
Tubing Set, Irrigation, PC, for
single use, sterile, package of 10	031523-10	Class I
Tubing Set, Suction, BS, for	031647-10	Class I
	single use, sterile, package of 10
Tubing Set, Suction, OS, for single use, sterile, package of 10	030647-10	Class I
Tubing Set, Irrigation, FC, for single use, sterile, package of 10	031524-10	Class I
Tubing Set, Irrigation, CV, for single use, sterile, package of 10	031529-10	Class I
Intended Use:	Suction/irrigation pumps and their accessories are used for the introduction of irrigation fluids into organs, joints and operating fields as well as the suctioning off of irrigation fluids and bodily fluids, secretions, tissue and gas during diagnostic or therapeutic interventions.
Indications for Use	Endomat Select is intended to:
• provide the infusion of the sterile irrigant solutions into the ureter and upper urinary tract, as well as to suction off the irrigations fluids, bodily fluids, secretions, tissue and gas during diagnostic and operative endoscopic urological procedures
• provide liquid distention of the uterus for diagnostic and operative hysteroscopy
• provide the infusion of the sterile irrigant solutions into organs and operating fields during diagnostic and operative procedures in laparoscopic and open general surgery
• provide sustained liquid irrigation and distention of joint or intra-articular spaces during all phases of arthroscopic surgery
• provide the infusion of the sterile irrigant solutions in order to enable the Lens Cleaning during endoscopically assisted Functional Endoscopic Sinus Surgery and endoscopically

6

Image /page/6/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters.

7

Image /page/7/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, bold, blue letters on the bottom line.

		assisted transnasal pituitary gland surgery
		** The above Indications for Use represent a combination of the
indications for the cited predicate devices and therefore there is no new
intended use. **
Technological
Characteristics:	The proposed subject device is a multifunctional design that
incorporates the functionality of multiple predicate devices.
The technological differences between each of the subject
device's functions and the respective predicate devices are
summarized in the Table 1.1. below, and they do not raise
any different issues of safety and effectiveness.
Non-Clinical
Performance Data:	The Endomat Select follows the FDA recognized consensus
standards and is tested according to the following standards
and FDA Guidances:
Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-1-8 Software Verification and Validation Testing Guidance for the Content of Premarket
Submissions for Software Contained in
Medical Devices issued on May 11, 2005 Level of Concern: Major Summative Usability Testing IEC 62366 Performance Testing Hysteroscopic and Laparoscopic Insufflators:
Submission Guidance For A 510(K) issued on
August 1, 1995 for Product Code HIG Performance tests of pressure controlled
irrigation mode

8

Image /page/8/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

Performance tests of intrauterine pressure
Additional bench testing was performed to ensure the device
met its design specifications.
Verification Test	Conclusion
Performance:
Pressure Control	Pass
Performance:
Flow Limitation	Pass
Performance:
Flow Control	Pass
Performance:
Pressure Limitation	Pass
Performance:
Suction Control	Pass
Safety:
Overpressure Warning (in pressure relevant
GYN and URO interventions)	Pass
Safety:
Overpressure Warning (in pressure relevant
ARTHRO interventions)	Pass
Safety:
Overpressure Alarm
(in pressure relevant GYN and URO
interventions)	Pass
Safety:
Pressure Relief
(in pressure relevant GYN and URO
interventions)	Pass
The bench testing performed verified and validated that the
Endomat Select has met all its design specification and is
substantially equivalent to its predicate devices.
Clinical Performance Data:	Clinical testing was not required to demonstrate the
substantial equivalence to the predicate devices. Non-clinical
bench testing was sufficient to assess safety and effectiveness
and to establish the substantial equivalence.
Conclusion:	The non-clinical testing demonstrates that the device is as
safe, as effective and performs as well as or better than the
legally marketed predicate devices.

9

Image /page/9/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.

Table 1.1. Comparison of Technological Characteristics

	Subject Device	Predicate Devices by application
	Karl Storz	Applied Medical	World of Medicine	World of Medicine	Karl Storz	Artherex	Karl Storz	Karl Storz
	Endomat Select	EPIX	AQUILEX FLUID
CONTROL SYSTEM
H112	Uro Pro	Endomat LC	Dual Wave Arthroscopy
Pump	Clearvision	Clearvision
Lens Irrigation System
Application	Multi	Surgery
( Laparoscopy )	Hysteroscopic	Urological	Urological Suction	Arthroscopic	Lens Cleaning	Lens Cleaning

Design	Microprocessor
controlled, pressure
monitoring peristaltic
Pump for irrigation or
suction.	Microprocessor
controlled, peristaltic
pump for irrigation
with conduit for
external suction.	Microprocessor
controlled, pressure
monitoring peristaltic
pump for irrigation
and/or suction.	Microprocessor controlled,
pressure monitoring
peristaltic pump for
irrigation or suction.	Microprocessor
controlled, peristaltic
pump for suction.	Microprocessor
controlled, pressure
monitoring peristaltic
pump for irrigation and
suction.	Microprocessor
controlled, oscillatory
peristaltic pump	Microprocessor
controlled, oscillatory
peristaltic pump
Intended Use	Suction/irrigation
pumps and their
accessories are used
for the introduction of
irrigation fluids into
organs, joints and
operating fields as wel
as the suctioning off of
irrigation fluids and
bodily fluids,
secretions, tissue and
gas during diagnostic
or therapeutic
interventions.	The Epix® Suction
Irrigation System is
intended as a general
purpose suction
and/or irrigation
device for use in
laparoscopic and open
general surgery,
laparoscopic and oper
gynecological surgery,
laparoscopic and open
urologic surgery. This
device delivers sterile
irrigant solution and
serves as a conduit for
suction.	Aquilex™ Fluid Control
System is intended to
provide liquid
distension of the
uterus during
diagnostic and
operative
hysteroscopy, and to
monitor the volume
differential between
the irrigation fluid
flowing into and out of
the uterus.	The URO Pro is an irrigation
roller pump intended for
the infusion of sterile
solutions into the ureter
and upper urinary tract
during diagnostic and/or
therapeutic endoscopic
urologic procedures. It is
indicated for the infusion of
sterile solutions through an
endoscope into the
urogenital tract to irrigate
the ureter or upper urinary
tract in a controlled
manner and to improve
visibility of the surgical
field during urologic
procedures.	Suction/irrigation pumps
and their accessories are
used for the introduction
of irrigation fluids into
organs, joints and
operating fields as well
as the suctioning off of
irrigation fluids and
bodily fluids, secretions,
tissue and gas during
diagnostic or therapeutic
interventions.	The AR-6480 is intended
to provide continuous
pulse-free flow that
reacts immediately to
changes in the intra-
articular pressure so that
joint distention can be
sustained even under
high shaver extraction
volumes or secondary
outflow.	Irrigation pumps and
their accessories are
used for the introduction
of irrigation fluids into
organs and operating
fields during endoscopic
interventions. The
clearvision is a lens
irrigation pump for the
fields of ENT and
Neurosurgery.	The KSEA Clearvision is
a lens irrogation system
for cleaning the lens
and maintaining clear
visualization without
removing the scope
from
the surgical site during
sinus surgery.

10

Image /page/10/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.

KARL STORZ Premarket Notification

Endomat Select

Summary of Safety and Effectiveness

| | HIG, BTA, LJH, OCX,
HRX, GWG, EOB | BTA | HIG | LJH | OCX | HRX | GWG | EOB |
|-----------------------------------------------|---------------------------------------------------|-----------------------------------------------------|-----------------------------------------------|------------------------------------------------|--------------------------------------------------|----------------------------------------------------------------------------|----------------------------|----------------------------|
| Procode | | | | | | | | |
| Pressure
measurement
location and | Yes, dual pressure
sensors at the pump
head | No pressure
measurement | Yes, single transducer
at the pump head | Yes, dual pressure sensors
at the pump head | No pressure
measurement | Yes, dual sensor | No pressure
measurement | No pressure
measurement |
| User
interface/Selection
of Application | LCD touch screen | Digital flowrate display
and membrane
buttons | Digital display and button | Digital display and
membrane buttons | Digital flowrate display
and membrane buttons | LCD touch screen | On/Off | On/Off |
| Overpressure
Safety | Yes, using software
and roll pump reversal | No | Yes, using software
and roll pump reversal | Yes, using software and roll
pump reversal | N/A | Software controlled
pump stops at

300mmHg (IFU
recommends manual | N/A | N/A |
| Features | | | | | | | | |
| Indicates
Operating | Yes | No | Intrauterine | Yes | No | Yes | No | No |
| Alarm for over
Pressure | Yes | No | Yes | Yes | No | Yes | No | No |
| Volume difference
monitor | No | No | Yes | No | No | No | No | No |
| Indicates
Operating Fluid
Flow | Yes | Yes | No | Yes, nominal set point | No | No | No | No |
| Alarm for over
Fluid Flow | Yes | No | Yes | Yes | No | No | No | No |
| Indicates
Maximum Suction
Pressure | No | No | No | No | No | No | No | No |
| Alarm for over
Suction Pressure | No | No | No | No | No | No | No | No |
| Accessories | | | | | | | | |
| Foot Switch | Yes | No | No | No | Yes | Yes | Yes | Yes |
| Tubing Sets | Yes | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| External pressure
sensor (optional) | No | No | No | No | No | No | No | No |

11

Image /page/11/Picture/0 description: The image shows the logo for STORZ. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE", also written in blue. The logo is simple and professional.

Summary of Safety and Effectiveness

Performance
Irrigation Pressure
Lap/Surgical	100,300 and 500mmHg	Not Given
Hysteroscopic	20-150mmHg		40-150 mmHg
Urological	20-150mmHg			15-150 mmHg
Urological suction	N/A				N/A
Arthroscopy	20-150mmHg					10-120 mmHg
Clearvision	N/A						N/A
Clearvision	N/A							N/A
Irrigation Flow
Lap/Surgical	100-3500ml/min	2, 3 or 4 L/min
Hysteroscopic	200, 400, 600ml/min		0-800ml/min
Urological	200, 400, 600ml/min			0-500ml/min
Urological suction	N/A				N/A
Arthroscopy	1500,2000,2500ml/min					0 - >1,500ml/min
Clearvision	50,65,80,95,110,130ml/min						85 ml/min
Clearvision	50,65,80,95,110,130ml/min							40 ml/min
Suction Pressure
Lap/Surgical	N/A	N/A
Hysteroscopic	N/A		- 500 mmHg
Urological	N/A			N/A
Urological suction	-0.95 Bar (-712.5mmHg)				-0.95 Bar (-712.5mmHg)
Arthroscopy	N/A					Not Given
Clearvision	N/A						N/A
Clearvision	N/A							N/A
Suction Flow
Lap/Surgical	N/A	N/A
Hysteroscopic	N/A		N/A
Urological Resection	0-1000ml/min			N/A
Urological suction	300-1000ml/min				0-1000 ml/min
Arthroscopy	N/A					N/A
Clearvision	N/A						N/A
Clearvision	N/A							N/A