(212 days)
Not Found
No
The device description focuses on the physical components and materials of a reusable surgical hysteroscope and its accessories. There is no mention of software, image processing, AI, ML, or any data analysis capabilities that would suggest the use of such technologies. The performance studies described are related to thermal and simulated use testing, not algorithmic performance.
No
Explanation: A therapeutic device is one that treats or cures a disease or condition. This device is used for diagnostic and surgical procedures, meaning it helps to identify a condition or aids in a surgical intervention, but does not inherently provide therapy itself.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for the purpose of performing diagnostic and surgical procedures."
No
The device description clearly details physical components made of surgical grade stainless steel, glass, acrylic, and Ultem, indicating it is a hardware device, not software-only.
Based on the provided information, the AED Hysteroscope and Accessories is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures." This describes a device used within the body for visualization and intervention, not for testing samples outside the body.
- Device Description: The description details a surgical device with lenses, sheaths, and channels for fluid and instruments. This aligns with a surgical endoscope, not an IVD device which typically involves reagents, analyzers, or test kits for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the AED Hysteroscope and Accessories is a surgical device used for visualization and procedures within the body, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
HIH
Device Description
AED Hysteroscopes
5705B AED Hysteroscope
4.0mm diameter, 30° Angle of View, 36cm length, 30cm working length
5729B AED Hysteroscope
2.9mm diameter, 30° Angle of View, 36cm length, 30cm working length
AED Sheaths
Examination Sheaths
18-2305 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
5.0mm diameter, 31cm length, 26cm working length, 1 stopcock
18-2306 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope
4.0mm diameter, 31cm length, 26cm working length, 1 stopcock
18-2304 Continuous Flow for use with a 2.9mm diameter, 30° Angle of View Hysteroscope
Inner Sheath: 3.8mm diameter, 27cm length, 25cm working length, 1 stopcock
Outer Sheath: 4.5mm diameter, 24cm length, 18cm working length, 1 stopcock
18-2309 Continuous Flow for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
Inner Sheath: 5.2mm diameter, 27cm length, 25cm working length, 1 stopcock
Outer Sheath: 6.2mm diameter, 24cm length, 18cm working length, 1 stopcock
18-2313 5.1mm diameter, 1 luer lock adapter
5.1mm diameter, 31cm length, 26cm working length, 1 stopcock with luer adapter
18-2314 5.1mm diameter. 1 luer lock adapter. rotatable
5.1mm diameter. 31cm length. 26cm working length. 1 rotatable stopcock with luer adapter
Examination/Operative Sheaths
18-2300 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 1 Rotatable Stopcock
5.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter
18-2302 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope 1 Instrument Channel and 1 Rotatable Stopcock
4.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter
18-2307 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 2 Stopcocks
5.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter , Continuous Flow
18-2308 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 2 Stopcocks
4.0mm diameter, 31cm length, 22cm working length
2.0mm Channel Diameter, Continuous Flow
The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths.
The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.
Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon.
There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309).
The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Direct viewing
Anatomical Site
cervical canal and the uterine cavity
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)
Performance Testing:
Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate devices. The AED Hysteroscope and Accessories met all specified design and performance requirements.
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
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of three overlapping profiles.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 7, 2015
National Advanced Endoscopy Devices. Inc. Gayle Butler Compliance Manager 22134 Sherman Way Canoga Park CA 91303
Re: K141515
Trade/Device Name: AED Hysteroscope And Accessories Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: November 24, 2014 Received: December 4, 2014
Dear Gayle Butler,
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. 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
1
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.
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/Resourcesfor You/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 -A
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) K141515
Device Name AED Hysteroscope and Accessories
Indications for Use (Describe)
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Type of Use (Select one or both, as applicable)
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 CHILL CHILL CHE CHE CHARRE OF CHE
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
National Advanced Endoscopy Devices, Inc.
Premarket Notification: K141515
510(k) Summary of Safety and Effectiveness
| Date: | December 22, 2014 | |
|---|---|---|
| Submitter: | National Advanced Endoscopy Devices, Inc. | |
| 22134 Sherman Way | ||
| Canoga Park, CA 91303 | ||
| Telephone: 818.227.2720 | ||
| Fax: 818.227.2724 | ||
| Contact Person: Gayle M. Butler | ||
| Compliance Manager | ||
| Product: | Trade Name: | |
| Classification: | ||
| Common Name: | ||
| Classification Name: | AED Hysteroscope and Accessories | |
| Class II | ||
| Hysteroscope and Accessories | ||
| Hysteroscope (And Accessories) | ||
| (HIH, 21 CFR 884.1690) | ||
| Predicate Devices: | Karl Storz Fixed Magnification Telescope/KS Variable | |
| Magnification Telescope K935716 | ||
| Device | ||
| Description: | AED Hysteroscopes | |
| 5705B AED Hysteroscope | ||
| 4.0mm diameter, 30° Angle of View, 36cm length, 30cm working length | ||
| 5729B AED Hysteroscope | ||
| 2.9mm diameter, 30° Angle of View, 36cm length, 30cm working length | ||
| AED Sheaths | ||
| Examination Sheaths | ||
| 18-2305 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope | ||
| 5.0mm diameter, 31cm length, 26cm working length, 1 stopcock | ||
| 18-2306 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope | ||
| 4.0mm diameter, 31cm length, 26cm working length, 1 stopcock | ||
| 18-2304 Continuous Flow for use with a 2.9mm diameter, 30° Angle of View | ||
| Hysteroscope | ||
| Inner Sheath: 3.8mm diameter, 27cm length, 25cm working length, 1 stopcock | ||
| Outer Sheath: 4.5mm diameter, 24cm length, 18cm working length, 1 stopcock |
4
18-2309 Continuous Flow for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
Inner Sheath: 5.2mm diameter, 27cm length, 25cm working length, 1 stopcock Outer Sheath: 6.2mm diameter, 24cm length, 18cm working length, 1 stopcock
18-2313 5.1mm diameter, 1 luer lock adapter
5.1mm diameter, 31cm length, 26cm working length, 1 stopcock with luer adapter
18-2314 5.1mm diameter. 1 luer lock adapter. rotatable
5.1mm diameter. 31cm length. 26cm working length. 1 rotatable stopcock with luer adapter
Examination/Operative Sheaths
18-2300 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 1 Rotatable Stopcock
5.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter
18-2302 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope 1 Instrument Channel and 1 Rotatable Stopcock
4.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter
18-2307 for use with a 4.0mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 2 Stopcocks
5.0mm diameter, 31cm length, 22cm working length, 2.0mm Channel Diameter , Continuous Flow
18-2308 for use with a 2.9mm diameter, 30° Angle of View Hysteroscope
1 Instrument Channel and 2 Stopcocks
4.0mm diameter, 31cm length, 22cm working length
2.0mm Channel Diameter, Continuous Flow
The AED Hysteroscope and Accessories is a reusable surgical device that incorporate operative and examination sheaths.
The AED Hysteroscope is a reusable rod lens Hysteroscope consisting of an eyepiece lens and a light post connection for fiber optic light cables. A shaft composed of surgical grade stainless steel encloses the glass rod-lens system and a built-in fiber optic light carrier made of glass/acrylic. The light post body is also comprised of surgical stainless steel. The eyepiece is made from Ultem.
Examination Sheaths are designed to be used with a hysteroscope alone. An operative sheath is an examination sheath with one or more instrument channels. The operative and examination sheaths are composed of surgical grade stainless steel with the exception of a Fixing Ring (where applicable) which is composed of Nylon.
5
There are two designs for Continuous Flow Sheaths. One design consists of a single sheath with two interior channels (18-2307 and 18-2308) for the inflow and outflow of media to be used with the hysteroscope alone. Alternatively, an inner and outer sheath may be used to perform the same function (18-2304 and 18-2309).
The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.
Indication for Use:
AED Hysteroscope and Accessories are used to permit direct viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Comparison of Technological Characteristics:
The AED Hysteroscope and Accessories has the same fundamental technological characteristics as the predicate devices and is substantially equivalent in design, materials and intended use as the predicate devices.
Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope (K935716):
- Same Indications for Use ●
- Utilizes the Same Operating Principle ●
- Same Basic Mechanical Design ●
- Manufactured Using the Same Materials
The AED Hysteroscope and Accessories differ from the predicate device Karl Storz Fixed Maqnification Telescope/KS Variable Magnification Telescope (K935716):
- The KS Variable Magnification Telescope has an ● adjustable ocular lens that can, using an exterior knob, be moved to adjust magnification to 80x. The AED Hysteroscope has a fixed nonadjustable ocular lens.
6
National Advanced Endoscopy Devices, Inc.
There is no difference between the Karl Storz Fixed Maqnification Telescope and the AED Hysteroscope.
Performance Testing:
Testing was performed according to IEC 60601-2-18. Thermal testing and simulated use testing were performed to support safety and effectiveness and substantial equivalence to the predicate devices. The AED Hysteroscope and Accessories met all specified design and performance requirements.
Performance
Standards:
The device conforms to ISO 8600-4:2014, 8600-1:2013, 8600-3:1997 Amendment 1 2003, 8600-5:2005, 8600-6:2005 and IEC 60601-2-18 (1996) and IEC 60601-2-18 Edition 3.0 2009-08.
- Conclusion: Based on the technical information, intended use and performance information provided in this premarket notification, the AED Hysteroscopes and Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.