(266 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on a standard videoscope.
No
The device is indicated for diagnostic and therapeutic procedures, but the "Device Description" clarifies it is a visualization tool for examination. It does not perform therapeutic actions itself.
Yes
The intended use statement explicitly mentions "diagnostic" procedures, indicating its role in identifying or characterizing medical conditions.
No
The device description explicitly states it is a "reusable, flexible videoscope" and mentions a "CMOS chip" as the input imaging modality, indicating it is a hardware device with integrated components, not solely software.
Based on the provided information, the KARL STORZ Slim Nasopharyngoscope System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used to "provide visualization and access of the nasal lumens and airway anatomy... during diagnostic and therapeutic procedures." This describes a device used in vivo (within the body) for direct visualization and access, not for testing samples in vitro (outside the body).
- Device Description: The description confirms it's a "reusable, flexible videoscope used for examination of the nasal lumens and airway anatomy." This further reinforces its use for direct examination within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information about a patient's health status based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a tool for direct visualization and access within the body.
N/A
Intended Use / Indications for Use
The KARL STORZ Slim Nasopharyngolaryngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.
Product codes
EOB
Device Description
The KARL STORZ Slim Nasopharyngolaryngoscope (Model Number: 11161V) is a reusable, flexible videoscope used for examination of the nasal lumens and airway anatomy. The KARL STORZ Slim Nasopharyngolaryngoscope System is identical to the KARL STORZ Flexible Video-Neuro-Endoscope System, which is currently distributed under K161112.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal lumens and airway anatomy (including nasopharyngeal and trachea)
Indicated Patient Age Range
adult and pediatric patients
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
Non-Clinical Performance Data: Electrical Safety and Electromagnetic Compatibility Summary, Bench Testing Summary, Biocompatibility Summary, High Level Disinfection (HLD) Summary
Clinical Performance Data: Clinical testing was not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym and name on the right. The seal is a stylized depiction of a human figure, while the FDA acronym and name are written in blue, with the acronym in a square and the name in a sans-serif font.
February 2, 2018
KARL STORZ Endoscopy-America, Inc. AnnaLisa Smullin Regulatory Engineer 2151 E. Grand Avenue El Segundo, CA 90245
Re: K171402
Trade/Device Name: KARL STORZ Slim Nasopharyngolaryngoscope Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: January 2, 2018 Received: January 3, 2018
Dear AnnaLisa Smullin:
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.
1
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 limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
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.
For comprehensive regulatory information about medical devices and radiation-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 yours,
Eric A. Mann -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171402
Device Name
KARL STORZ Slim Nasopharyngolaryngoscope System
Indications for Use (Describe)
The KARL STORZ Slim Nasopharyngoscope System is indicated to provide visualization and access of the nasal lumens and airway anatomy (including nasopharyngeal and trachea) during diagnostic and therapeutic procedures in adult and pediatric patients.
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 Drug 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."
3
Image /page/3/Picture/0 description: The image shows the logo for STORZ. The logo is blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional.
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: | AnnaLisa Smullin
Regulatory Engineer
Phone: (424) 218-8376
Fax: (424) 218-8519 |
| Date of
Preparation: | January 30, 2018 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ Slim Nasopharyngolaryngoscope
System
Classification Name: Nasopharyngoscope (21 CFR Part 874.4760) |
| Regulatory
Class: | II |
| Product Code: | EOB |
| Guidance
Document: | Not Applicable for EOB product code |
| Recognized
Consensus
Standards: | Not Applicable for EOB product code |
| Predicate
Device(s): | Primary Predicate Device: KARL STORZ Endoscopy-America's
Karl Storz Rhino-Laryngo-Broncho-Fiberscope (K981458)
Secondary Predicate Device: MAHE INTL., INC's MAHE Pediatric
Naso Pharyngoscope (K030857)
Reference: KARL STORZ Endoscopy-America's KARL STORZ
Flexible Video-Neuro-Endoscope System (K161112) |
| Device
Description: | The KARL STORZ Slim Nasopharyngolaryngoscope (Model
Number: 11161V) is a reusable, flexible videoscope used for
examination of the nasal lumens and airway anatomy. The KARL
STORZ Slim Nasopharyngolaryngoscope System is identical to the |
4
Image /page/4/Picture/0 description: The image is a logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
| | KARL STORZ Flexible Video-Neuro-Endoscope System, which is
currently distributed under K161112. | | | | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------------------|----------------------------------------------|---------------------------------------------------------------------------------------------------|--|
| Intended Use: | The KARL STORZ Slim Nasopharyngolaryngoscope System is
intended for visualization purposes during ENT diagnostic and
therapeutic procedures. | | | | | |
| Indications For
Use: | The KARL STORZ Slim Nasopharyngolaryngoscope System is
indicated to provide visualization and access of the nasal lumens and
airway anatomy (including nasopharyngeal and trachea) during
diagnostic and therapeutic procedures in adult and pediatric patients. | | | | | |
| Technological
Characteristics: | | Subject Device | Primary
Predicate
Device,
K981458 | Secondary
Predicate
Device,
K030857 | Reference
Device,
K161112 | |
| | | KARL STORZ
Slim
Nasopharyngo-
laryngoscope
System | KARL STORZ
Rhino-
Laryngo-
Broncho-
Fiberscope | MAHE
Pediatric
Nasopharyngo-
scope | KARL STORZ
Flexible Video-
Neuro-
Endoscope
System | |
| | | Physical Characteristics | | | | |
| | Type of
Scope | Flexible | Flexible | Flexible | Flexible | |
| | Distal Tip
Diameter | 8.5 Fr, 2.83 mm
(elliptical:
3.2 mm x 2.4 mm) | 3.5 mm | 2.8 mm | 8.5 Fr, 2.83 mm
(elliptical:
3.2 mm x 2.4 mm) | |
| | Working
Shaft
Length | 350 mm | 340 mm | 300 mm | 350 mm | |
| | Working
Channel
Diameter | 1.2 mm | 1.2 mm | No working
channel | 1.2 mm | |
| | Deflection
(°) | Up: 270°
Down: 270° | Up: 180°
Down: 100° | Up: 120°
Down: 100° | Up: 270°
Down: 270° | |
| | Optical Characteristics | | | | | |
| | Type of
Imager | CMOS chip | Fiberscope | Fiberscope | CMOS chip | |
| | Field of
View | 90° | 85° | 95° | 90° | |
| | Direction of
View | 0° | 0° | 0° | 0° | |
| | Light
Source | Internal LED | External Xenon | External LED | Internal LED | |
| | Cleaning and Sterilization Methods | | | | | |
| | Cleaning | Manual | Manual | Manual | Manual | |
| | Sterilization | - STERRAD NX
- STERRAD
100NX - STERIS
SYSTEM 1E - V-PRO maX
- V-PRO 60
- EtO | - EtO | Unknown | - STERRAD NX
- STERRAD
100NX - STERIS
SYSTEM 1E - V-PRO maX
- V-PRO 60
- EtO | |
| | HLD | - CIDEX | - CIDEX | Unknown | No HLD | |
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 a smaller font.
| Non-Clinical
Performance
Data: | Electrical Safety and Electromagnetic Compatibility Summary
The device design, including the electrical safety and
electromagnetic compatibility (EMC), has not changed since
clearance of the reference device, the KARL STORZ Flexible Video-
Neuro-Endoscope System in K161112. The electrical safety and
EMC data submitted in K161112 was in compliance with the
following FDA recognized standards:
• ANSI/AAMI ES 60601-1:2005 (Recognition Number: 19-4)
• IEC 60601-1-2:2007 (Recognition Number: 19-8)
As the subject device remains identical to the reference device, no
additional electrical safety or EMC data is needed for the KARL
STORZ Slim Nasopharyngolaryngoscope System.
Bench Testing Summary
The device design, including the performance has not changed since
clearance of the reference device, the KARL STORZ Flexible Video-
Neuro-Endoscope System in K161112. The performance data
submitted in K161112 was in compliance with the following FDA
recognized standards:
• ISO 8600-1: Fourth edition: 2015-10-15 (Recognition
Number: 9-110)
• ISO 8600-3: First edition: 1997-07-01 (Recognition Number:
9-84)
• ISO 8600-4: Second edition: 2014-03-15 (Recognition
Number: 9-94)
As the subject device remains identical to the reference device, no
additional performance data is needed for the KARL STORZ Slim
Nasopharyngolaryngoscope System.
Biocompatibility Summary
The device design, including the materials, has not changed since
clearance of the reference device, the KARL STORZ Flexible Video-
Neuro-Endoscope System in K161112.The Biological Evaluation
data submitted in K161112 was in compliance with the following
FDA recognized standards:
• ISO 10993-1:2009/(R) 2013 (Recognition Number: 2-156)
• ISO 10993-5:2009/ (R) 2014 (Recognition Number: 2-153)
• ISO 10993-10:2010 (Recognition Number: 2-173)
• ISO 10993-11:2006/ (R) 2010 (Recognition Number: 2-118)
As the subject device remains identical to the reference device, no
additional biological evaluation data is needed for the KARL
STORZ Slim Nasopharyngolaryngoscope System. |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | High Level Disinfection (HLD) Summary |
| | The reference device, the KARL STORZ Flexible Video-Neuro-
Endoscope System (K161112), is a critical device per Spaulding
Classification, whereas the subject device is a semi-critical device,
requiring a thorough cleaning followed by sterilization or high level
disinfection (HLD). In order to support an additional HLD method
(CIDEX), a new HLD validation study was performed using a
representative device. The HLD data submitted was in compliance
with the following FDA standards. Where applicable, FDA standard
recognition numbers are noted:
• AAMI TIR12: 2010
• ISO 15883-5:2005
• AAMI TIR30:2011
• AAMI/ANSI/ISO 11737-1:2006/ (R)2011 (Recognition
Number: 14-227)
• ASTM E1837-96:2014 |
| Clinical
Performance
Data: | Clinical testing was not required to demonstrate substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish the substantial equivalence of the
modifications. |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that
the subject device, KARL STORZ Slim Nasopharyngolaryngoscope
System performs as well as or better than the legally marketed
predicate devices. |
6
Image /page/6/Picture/0 description: The image is a logo for "STORZ KARL STORZ - ENDOSKOPE". The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters.