(189 days)
No
The summary describes a standard hysteroscope and its intended use, materials, and sterilization. There is no mention of AI, ML, image processing, or any software-driven analysis of the visual data. The performance studies focus on material safety and equivalence to predicate devices, not algorithmic performance.
No
The device is a hysteroscope used for viewing and accessing the uterine cavity to perform diagnostic and surgical procedures, but it does not directly provide therapy. It is a tool used by surgeons to facilitate therapeutic procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the AlphaScope Hysteroscope is used for "performing diagnostic and surgical procedures."
No
The device description explicitly states it is a "Hysteroscope," which is a physical medical instrument used for viewing the cervical canal and uterine cavity. It also mentions being re-useable and sterilizable, indicating a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- AlphaScope Hysteroscope Function: The AlphaScope Hysteroscope is used to directly view the cervical canal and uterine cavity inside the body. It's a tool for visualization and performing procedures in vivo.
The description clearly states its purpose is for "viewing of the cervical canal and the uterine cavity" and for "performing diagnostic and surgical procedures" within these anatomical sites. This is an in vivo procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
Product codes
HIH
Device Description
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants.
AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
endoscopic surgeons and qualified assistants.
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 Test Results: Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices.
Key Metrics
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
92421
510(k) Summary
FEB 1 2 2010
Responsible Persons:
Bernd Maier, Director of OEM Business (responsible for Design evaluation) Reinhold Blazejewski, Fa.MediTech, (responisible for production) Klaus Moser, Head of Service (responsible for Technical Requests) Ulrich Henzler/Gabriela Trompler, QAM (Responsible for Requlations and Documentation
Date Summary prepared: June 22, 2009
Device Name: AlphaScope Hysteroscope, fiber optic
Device Description (807.92):
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
The use of AlphaScope Hysteroscope is restricted for the use of endoscopic surgeons and qualified assistants.
AlphaScope Hysteroscopes are re-useable, they can be sterilized by 134 C Degrees Steam Autoclave
Classification accord. MDD 93/42 in Risk Class IIa Accord. CFR in Risk Class II
Common Name: Hysteroscopes and accessories
| Classification names | Product code | CFR Regulation # |
|---|---|---|
| Hysteroscope, fiberoptic | 85 HIH | 884.1690 |
1
Indications for Use (807.92)
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
Industry Standards/Performance Data (808.92)
We certify the conformity with all European Norms and directives. AlphaScope Hysteroscopes and their accessories are CE-marked.
Also they are in conformity with relevant ISO/EN/ASTM/AAMI/ANSI/IEC and other device-related standards that apply to the manufacture, packaging, labelling, reprocessing, traceability including the validation of these processes. Also we are monitoring these devices using statistics and market observation.
Summary of Testing
All materials used in the composition of AlphaScope Hyseroscopes and their accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices.
The market observation of AlphaScope Hysteroscope, rigid, with diameter of 2,7 mm has shown that the used materials are not effect the safety of the patients.
All results were in conformance with the cited harmonized device standards and filed.
Information Bearing on the Safety and Effectiveness (807.92)
AlphaScope Hysteroscop has the same intended use as the predicate devices. It is made of the same materials as one of the predicate device (Alpha Hysteroscope, K012869) and is produced to the same international and FDA-recognized standards. Slight modifications in design, diameter and material do not adversely affect the safety and effectiveness of these devices.
In summary, the
- . Intended use
- Performance attributes .
- . Materials and
- Basic design .
are identical and substantially equivalent to SE devices and to K012869 application.
2
Labeling
Package Label: All devices are packed in special designed boxes. The Packing was validated (Drop Test).
Affixed to each Box is a label that identifies the enclosed product. Please see Labels in Appendix V
Every product is carrying the product item number, CE-Mark and Serial Number of the device (Please see description, Appendix VII)
Operating Instructions are delivered with the AlphaScopeHysteroscope. Please see sample in Appendix I .
Reprocessing and Sterilization
AlpahaScope Hysteroscopes are delivered non-sterile and they were tested for effective Cleaning Possibility and for effective Sterilisation (see Validation report of Nelson Lap, Appendix IV).
All validated Reprocessing and Sterilization instructions are given in the Operating Manual.
Material
Most of the components are Surgical grade stainless steel and in conformance with FDA consensus standards. SE devices are using the same materials for their scopes.
Biocompatibility was tested by MDT (Rigid AlphaHysteroscope)
Standards
DIN 58105 Medical Endoscopes ISO 8600-1 Endoscopes and Phototonic; General Requirements ISO 8600-2 Endoscopes and Phototonic; Special Requirements for Bronchoscopes ISO 8600-3 Endoscopes and Phototonic; Definition of Viewing Field and Viewing Angle ISO 8600-4 Endoscopes and Phototonic; Definition of maximal size of Insertion part ISO 8600-5 Endoscopes and Phototonic; Definition of the resolution ISO 8600-6 Endoscopes and Phototonic; Definitions DIN EN ISO 9001; Quality Management System DIN EN 13485 Quality Management System for Medical devices DIN EN 14971 Requirements for Risk Management Medical devices DIN EN 60601-2-18; Special Requirements for the Safety including of the basic performance of Endoscopic Equipment DIN EN ISO 10088-1; Stainless Steel DIN EN ISO 7153-1; Surgical Instruments; Part 1 Stainless Steel
3
DIN EN 17664; Sterilization of Medical Devices DIN EN 1041; Requirements for the Information provided by the Manufacturer DIN EN 980; Symbols for Identification of Medical Devices DIN EN 22 248 (ISO 2248) Drop Test USFDA (21 CFR Part 58) Sterilization Validation AAMI TIR12:2004 AAMI TIR.2003 ANSI/AAMI ST81:2004 ANSI/AAMI ST89:2006 ASTM E 1837 (1996) FDA: CRD 183 FDA; CRD 255 FDA; CRD 256 HTM; CRD 259
Non-Clinical Test Results
Based on the equivalence in design and materials to predicate devices, performance testing was not warranted. The device meets the same criteria and is as effective and safe as SE devices.
Tuttlingen, June 22, 2009
Thilo Henzler President Bernd Maier Director
Klaus Moser Head of Service Ulrich Henzler QAM
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest the shape of a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
GIMMI GmbH c/o Mr. Ken Blake V.P. and General Manager Scanlan International One Scanlan Plaza SAINT PAUL MN 55107
FFB 1 2 2010
Re: K092421
Trade Name: AlphaScope Hysteroscope Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories Regulatory Class: II Product Code: HIH Dated: January 20, 2010 Received: January 25, 2010
. Dear Mr. Blake:
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 of medical device-related
5
Page 2 -
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Abbreviated 510(k)
510(k) Number: Hysteroscope, fiberoptic, Common Name: AlphaScope Hysteroscope, fiberoptic, operative and diagnostic Device Name: Predicate Device The AlphaScope Hysteroscope is substantially equivalent to the following Name: predicate devices: MicroSpan Gold Hysteroscope (K972426) Alpha Hysteroscope, Rod Lenses (K012869) 21 CFR § 884.1690 Product code 85 HIH Classification:
Indications for Use
Class II
AlphaScope Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
AlphaScope Hysteroscope is used with Hysteroscope Sheaths to provide access to the uterine cavity during diagnostic and operative hysteroscopic procedures.
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) (Division Sign-Un)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
OT
Over-The-Counter Use
.
Prescription Use