(269 days)
Not Found
No
The description focuses on microprocessor control, pressure/flow monitoring, and user interface, with no mention of AI or ML capabilities.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device is used in "therapeutic interventions," such as laparoscopy, pediatric laparoscopy, TEO, colonoscopy, and endoscopic vessel harvesting.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions." This indicates its role in diagnostic procedures.
No
The device description clearly states it includes "two microprocessor controlled CO2 insufflators" and describes physical components like pressure and flow monitoring, automatic pressure relief, and an integrated gas heater (in one model). These are hardware components, not software-only.
Based on the provided information, the ENDOFLATOR 40 & 50 are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ENDOFLATOR Function: The ENDOFLATOR 40 & 50 are used to create and distend cavities within the body during surgical and diagnostic procedures (laparoscopy, endoscopy, vessel harvesting). They are used in vivo (within the living body), not in vitro (outside the living body).
- Intended Use: The intended use clearly describes their function in surgical and diagnostic interventions performed directly on the patient.
- Device Description: The description details a device that controls gas flow and pressure for insufflation, which is a procedure performed on a living patient.
Therefore, the ENDOFLATOR 40 & 50 are surgical/endoscopic devices, not IVDs.
N/A
Intended Use / Indications for Use
The ENDOFLATOR 40 & 50 are used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions:
- · Laparoscopy
- · Pediatric Laparoscopy
- · Endoscopy of the Lower Gastrointestinal Tract (e.g., TEO, colonoscopy)
- · Endoscopic Vessel Harvesting
Product codes
HIF, OSV, FCX
Device Description
This submission includes two microprocessor controlled CO2 insufflators that have been developed in parallel: ENDOFLATOR 40 (Model Number: UI400) and ENDOFLATOR 50 (Model Number: UI500), both of which come with HIGH FLOW and PEDIATRICS modes. The HIGH FLOW mode has the pressure range of 1-30 mmHg and the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50 LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure range of 1-15 mmHg and the flow range of 0.1-15 LPM.
The ENDOFLATOR 40 &50 have redundant pressure and flow monitoring, automatic pressure relief, user control via graphical user interface and display of pressures/flow rates/ volume/operating mode.
The ENDOFLATOR 50 has three extra features not included in the ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2) the integrated gas heater, and (3) the ability for the user to save up to 30 procedure settings. Because the ENDOFLATOR 40 does not have the integrated gas heater, it can only be used with non-heated insufflation tubing set (Model Number: 031200-01). On the other hand, the ENDOFLATOR 50 (Model Number: UI500) can be used with either the non-heated insufflation tubing set (Model Number: 031200-01) or the heatable insufflation tubing set (Model Number: 031210-01).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peritoneal cavity, abdominal cavity, lower gastrointestinal tract
Indicated Patient Age Range
Adult and Pediatric
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 ENDOFLATOR 40 & 50 is tested according to the following standards:
• IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + AM1 (2012)
• IEC 60601-1-2:2014
• IEC 60601-1-18:2006/AMD1:2012
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff titled Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
In addition, the following bench testing has been performed for following safety and performance requirements as well as for comparative purposes:
Bench Testing Summary:
- Safety - Overpressure: The device informs user, if an unintended high cavity pressure is measured and activates appropriate valves if the activation threshold is exceeded. (Pass)
- Performance -- Pressure: The difference between the measured and the set point pressures is within the specified limits. (Pass)
- Safety -Maximum pressure: The measured pressure shall not exceed the mode related specified limits. (Pass)
- Safety - Overpressure: The gas flow is stopped if a cavity pressure is measured is higher than mode related limits. (Pass)
- Performance - Gas supply: The device informs the user if the pressure gas supply falls under specified limits. (Pass)
- Performance -- Flow: The difference between the measured and the set point flow is within the specified limits. (Pass)
- Safety - Pressure Controller: The pressure controller temperature shall stain within the specified limits. (Pass)
- Safety - Overtemperature: (ENDOFLATOR 50 only)The heater is switched off if the fault arises. (Pass)
- Performance - Heater connection symbol: (ENDOFLATOR 50 only) The heater connection symbol is correctly displayed. (Pass)
- Comparative -- Adult and Pediatric Laparoscopy: To support laparoscopy indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Standard/Bariatric modes and the secondary predicate device's Normal Cavity mode. Similarly, to support Pediatric Laparoscopy indication of the subject device, the pressure control of Pediatrics mode must be substantially equivalent to the primary predicate device's Pediatric mode. (SE to predicate devices)
- Comparative - Lower Gastrointestinal Tract: In order to support lower gastrointestinal indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the secondary predicate device's Small Cavity mode. (SE to predicate devices)
- Comparative - Endoscopic Vessel Harvesting: In order to support Endoscopic Vessel Harvesting indication of the subject device, the pressure control of High Flow mode must be substantially equivalent to the primary predicate device's Vessel Harvesting mode and the secondary predicate device's Small Cavity mode. (SE to 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 of the modifications.
Conclusion: The conclusions drawn from the nonclinical tests such as the software data, the electrical safety and performance data, as well as the bench top performance data, demonstrated the subject device is as safe as and as effective as the primary and secondary predicate devices. As such, we concluded that the substantial equivalence of the subject and both predicate devices has been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1730 Laparoscopic insufflator.
(a)
Identification. A laparoscopic insufflator is a device used to facilitate the use of the laparoscope by filling the peritoneal cavity with gas to distend it.(b)
Classification. (1) Class II (performance standards).(2) Class I for tubing and tubing/filter kits which include accessory instruments that are not used to effect intra-abdominal insufflation (pneumoperitoneum). 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.
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Image /page/0/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 a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 2, 2017
Karl Storz Endoscopy-America, Inc. Nozomi Yagi, MAS, RAC Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K161554
Trade/Device Name: ENDOFLATOR 40 & 50 Regulation Number: 21 CFR§ 884.1730 Regulation Name: Laparoscopic Insufflator Regulatory Class: II Product Code: HIF, OSV, FCX Dated: January 26, 2017 Received: January 27, 2017
Dear Nozomi Yagi:
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, 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.
1
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 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Benjamin R. Fisher -S
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
Indications for Use
510(k) Number (if known) K161554
Device Name ENDOFLATOR 40&50
Indications for Use (Describe) The ENDOFLATOR 40 & 50 are used to create and/or to distend a cavity in the following diagnostic and therapeutic interventions:
- · Laparoscopy
- · Pediatric Laparoscopy
- · Endoscopy of the Lower Gastrointestinal Tract (e.g., TEO, colonoscopy)
- · Endoscopic Vessel Harvesting
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED:
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nozomi Yagi
Regulatory Affairs Specialist
Phone: (424) 218-8351
Fax: (424) 218-8519 |
| Date of
Preparation: | February 28, 2017 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: ENDOFLATOR 40 and ENDOFLATOR 50
Classification Name: Insufflator, Laparoscopic (21 CFR Part
884.1730) |
| Regulatory
Class: | II |
| Product Code: | HIF (Insufflator, Laparoscopic),
OSV(Insufflator, Endoscopic Vessel Harvesting),
FCX(Insufflator, Automatic Carbon-Dioxide For Endoscope) |
| Guidance
Document: | Hysteroscopic and Laparoscopic Insufflators: Submission Guidance
for a 510(k) issued on August 1, 1995 for Product Code HIF |
| Predicate
Device(s): | Primary Predicate Device: World of Medicine's Insufflator 50L FM
134 (K153513)
Second Predicate Device: Olympus Medical Systems Corp's High
Flow Insufflation Unit UHI-4 (K122180) |
| Device
Description: | This submission includes two microprocessor controlled CO2
insufflators that have been developed in parallel: ENDOFLATOR 40
(Model Number: UI400) and ENDOFLATOR 50 (Model Number:
U1500), both of which come with HIGH FLOW and PEDIATRICS
modes. The HIGH FLOW mode has the pressure range of 1-30 mmHg
and the flow rate range of 1-40 LPM (ENDOFLATOR 40) and 1-50
LPM (ENDOFLATOR 50). The PEDIATRICS mode has the pressure |
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Image /page/4/Picture/0 description: The image is a 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.
| range of 1-15 mmHg and the flow range of 0.1-15 LPM. | |||||
|---|---|---|---|---|---|
| The ENDOFLATOR 40 &50 have redundant pressure and flow | |||||
| monitoring, automatic pressure relief, user control via graphical user | |||||
| interface and display of pressures/flow rates/ volume/operating mode. | |||||
| The ENDOFLATOR 50 has three extra features not included in the | |||||
| the integrated gas heater, it can only be used with non-heated | |||||
| insufflation tubing set (Model Number: 031200-01). On the other | |||||
| hand, the ENDOFLATOR 50 (Model Number: UI500) can be used | |||||
| with either the non-heated insufflation tubing set (Model Number: | |||||
| 031200-01) or the heatable insufflation tubing set (Model Number: | |||||
| 031210-01). | ENDOFLATOR 40: (1) the higher maximum flow rate (50LPM), (2) | ||||
| the integrated gas heater, and (3) the ability for the user to save up to | |||||
| 30 procedure settings. Because the ENDOFLATOR 40 does not have | |||||
| Intended Use: | CO2 insufflators and their accessories are used to create and/or to | ||||
| distend a cavity during diagnostic or therapeutic endoscopic | |||||
| interventions. | |||||
| Indications For | |||||
| Use, | Subject Device | Primary predicate | |||
| device, K153513 | Secondary predicate | ||||
| device, K122180 | |||||
| Comparison | ENDOFLATOR | ||||
| 40&50 | W.O.M. Insufflator | ||||
| 50L FM134 | Olympus High Flow | ||||
| Insufflation Unit UHI- | |||||
| 4 | |||||
| Indication for Use | |||||
| The ENDOFLATOR | |||||
| 40&50 are used to create | |||||
| and/or to distend a cavity | |||||
| in the following diagnostic | |||||
| and therapeutic | |||||
| interventions: | The Standard, Pediatric | ||||
| and Bariatric operating | |||||
| modes of the device are | |||||
| indicated to fill and | |||||
| distend a peritoneal cavity | |||||
| with gas during a | |||||
| laparoscopic procedure. | This instrument is | ||||
| intended to insufflate the | |||||
| abdominal cavity and | |||||
| provides automatic suction | |||||
| and smoke evacuation to | |||||
| facilitate laparoscopic | |||||
| observation, diagnosis and | |||||
| Technological | |||||
| Characteristics: | W.O.M. Insufflator 50L FM134 was chosen for having the Indication | ||||
| for Use and Technological Characteristics most similar to the subject | |||||
| device. The subject device differs from the primary predicate in that | |||||
| an operation mode is not specific to indicated intervention; the subject | |||||
| device has HIGH FLOW mode to cover laparoscopy, endoscopy of | |||||
| lower GI tract, and endoscopic vessel harvesting indications and | |||||
| PEDIATRICS mode to cover pediatric laparoscopy indication. | |||||
| Olympus' High Flow Insufflation Unit UHI-4 was chosen as a | |||||
| secondary predicate device to support the substantial equivalence of | |||||
| the additional anatomical location of use (i.e., colon) that the primary | |||||
| predicate does not include. | |||||
| The subject device has the same Intended Use as both primary and | |||||
| secondary predicate devices. | |||||
| The subject and both primary and secondary predicate devices are CO2 | |||||
| insufflators that are used to create and maintain the cavity. There are | |||||
| similarities and differences in the technological characteristics | |||||
| including but not limited to the following: | |||||
| Subject Device | Primary predicate | ||||
| device, K153513 | Secondary | ||||
| predicate device, | |||||
| K122180 | |||||
| Distension | |||||
| Medium | CO2 | Same as the subject | |||
| device | Same as the subject | ||||
| device | |||||
| Indicated | |||||
| Population | Adult and Pediatric | Same as the subject | |||
| device | Adult | ||||
| Modes | High Flow, | ||||
| Pediatrics | Bariatric, | ||||
| Standard, | |||||
| Vessel Harvest, | |||||
| Pediatric | Normal Cavity, | ||||
| Small Cavity | |||||
| Maximum | |||||
| Flow Rate | 50 LPM | Same as the subject | |||
| device | 45 LPM | ||||
| Maximum | |||||
| Pressure | 30 mmHg | Same as the subject | |||
| device | 25 mmHg | ||||
| Overpressure | |||||
| Action | Visual and audible | ||||
| alarms followed by | |||||
| pressure relief after 5 | |||||
| seconds | Visual and audible | ||||
| alarms followed by | |||||
| pressure relief after 2- | |||||
| 5 seconds | Visual and audible | ||||
| alarms followed by | |||||
| pressure relief after 0 | |||||
| or 4.5 seconds | |||||
| Gas Supply | |||||
| Shortage | |||||
| Action | When cylinder | ||||
| pressure is below 1 | |||||
| bar, visual and | |||||
| audible alarms will be | |||||
| activated and | |||||
| insufflation stops | At 41°C, | ||||
| Information signal | |||||
| indicates that heating | |||||
| is switched off | At >42°C, visual and | ||||
| audible alarm | N/A, gas is not heated |
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Image /page/6/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 text "KARL STORZ - ENDOSKOPE" in a smaller font.
| | The differences do not raise different questions of safety and
effectiveness. | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Non-Clinical
Performance
Data: | The ENDOFLATOR 40 & 50 is tested according to the following
standards:
• IEC 60601-1:2005 + CORR.1:2006 + CORR.2:2007 + AM1
(2012)
• IEC 60601-1-2:2014
• IEC 60601-1-18:2006/AMD1:2012
Software verification and validation testing were conducted and
documentation was provided as recommended by FDA's Guidance for
Industry and FDA Staff titled Guidance for the Content of Premarket
Submissions for Software Contained in Medical Devices. The software
for this device was considered as a "major" level of concern, since a
failure or latent flaw in the software could directly result in serious
injury or death to the patient or operator.
In addition, the following bench testing has been performed for
following safety and performance requirements as well as for
comparative purposes: | | |
| | Bench Testing Summary
Verification Test
(Test#) | Acceptance Criteria | Conclusion |
| | Safety - Overpressure | The device informs user, if an unintended
high cavity pressure is measured and
activates appropriate valves if the
activation threshold is exceeded. | Pass |
| | Performance -- Pressure | The difference between the measured and
the set point pressures is within the
specified limits. | Pass |
| | Safety -Maximum pressure | The measured pressure shall not exceed the
mode related specified limits. | Pass |
| | Safety - Overpressure | The gas flow is stopped if a cavity pressure
is measured is higher than mode related
limits. | Pass |
| | Performance - Gas supply | The device informs the user if the pressure
gas supply falls under specified limits. | Pass |
| | Performance -- Flow | The difference between the measured and
the set point flow is within the specified
limits. | Pass |
| | Safety - Pressure Controller | The pressure controller temperature shall
stain within the specified limits. | Pass |
| | Safety - Overtemperature | (ENDOFLATOR 50 only)
The heater is switched off if the fault
arises. | Pass |
| | | | |
| | Performance - Heater
connection symbol | specified limits.
(ENDOFLATOR 50 only)
The heater connection symbol is correctly
displayed. | Pass |
| | Comparative -- Adult and
Pediatric Laparoscopy | To support laparoscopy indication of the
subject device, the pressure control of High
Flow mode must be substantially
equivalent to the primary predicate
device's Standard/Bariatric modes and the
secondary predicate device's Normal
Cavity mode.
Similarly, to support Pediatric Laparoscopy
indication of the subject device, the
pressure control of Pediatrics mode must be
substantially equivalent to the primary
predicate device's Pediatric mode. | SE to
predicate
devices |
| | Comparative - Lower
Gastrointestinal Tract | In order to support lower gastrointestinal
indication of the subject device, the
pressure control of High Flow mode must
be substantially equivalent to the secondary
predicate device's Small Cavity mode. | SE to
predicate
devices |
| | Comparative - Endoscopic
Vessel Harvesting | In order to support Endoscopic Vessel
Harvesting indication of the subject device,
the pressure control of High Flow mode
must be substantially equivalent to the
primary predicate device's Vessel
Harvesting mode and the secondary
predicate device's Small Cavity mode. | SE to
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 of the modifications. | | |
| Conclusion: | The conclusions drawn from the nonclinical tests such as the software
data, the electrical safety and performance data, as well as the bench
top performance data, demonstrated the subject device is as safe as
and as effective as the primary and secondary predicate devices. As
such, we concluded that the substantial equivalence of the subject and
both predicate devices has been met. | | |
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Image /page/7/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.