(196 days)
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No
The description focuses on the mechanical and optical components of the hysteroscopes and accessories, with no mention of AI or ML capabilities.
No.
The device is used for visualization and manipulation of tissue, which are diagnostic and surgical procedures, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "These generic devices are used to perform diagnostic and surgical procedures." The device provides visualization of the cervical canal and uterine cavity, which is a diagnostic function.
No
The device description clearly details physical hardware components made of surgical grade stainless steel and other materials, including telescopes, handle and shaft assemblies, and tip assemblies. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The GIMMI ALPHA Hysteroscopes and Accessories are used directly within the human body (cervical canal and uterine cavity) for visualization and surgical procedures. They do not analyze specimens taken from the body.
- Intended Use: The intended use clearly states "to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix" and "to perform diagnostic and surgical procedures." This describes a direct intervention and visualization within the body, not the analysis of a sample outside the body.
Therefore, based on the provided information, the GIMMI ALPHA Hysteroscopes and Accessories are medical devices used for direct visualization and surgical procedures within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
78 FBM, 85 HDC, 85 HET, 85 HHO, 85 HIH
Device Description
GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.
The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
cervical canal and the uterine cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified physicians
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All materials used in the composition of GIMMI ALPHA Hysteroscopes and Accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices. All results were in conformance with the cited harmonized device standards.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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
§ 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
4H.
Gimmi GmbH
Abbreviated 510(k)
MAR 11 2002
K012869
page 1 of 3
510(k) SUMMARY of Safety and Effectiveness 2. GIMMI GmbH
As required by Section 807.92(c)
-
2.1 Submitter: [807.92 (a)(1)] GIMMI GmbH Junkerstr. 1 D-78532 Tuttlingen Germany
Tel. +49-7461 - 9 65 90-0 Fax +49-7461 - 9 65 90-33 e-mail info@gimmi.de -
2.2 Contact Person: [807.92 (a)(1)] Dagmar S. Mäser Business Support International +31-20-428 95 91 Amstel 320-l Tel. +31-20-428 94 29 1017 AP Amsterdam Fax bsi@xs4all.nl eMail The Netherlands
2.3 Date Summary Prepared: [807.92 (a)(1)} November 30, 2001
- 2.4 Device Names: [807.92 (a)(2)] GIMMI ALPHA Hysteroscopes & Accessories Proprietary
Common
Endoscopic Instruments & Accessories
| Classification Names | Product Codes | CFR Reg'n |
|---|---|---|
| Cannula & Trocar, Suprapubic, | ||
| Non-Disposable | 78 FBM | 876.5090 |
| Tenaculum, Uterine | 85 HDC | 884.4530 |
| Laparoscope, Gynecologic (and | ||
| Accessories) | 85 HET | 884.1720 |
| Screw, Fibroid, Gynecological | 85 HHO | 884.4530 |
| Hysteroscope & Accessories | 85 HIH | 884.1690 |
2-1
1
Instrument, Manual, Specialized (Obstetric-Gynecologic) Endoscope & Accessories
- 2.5 Reason for Submission: New Devices
- 2.6 Predicate Devices: [807.92 (a)(3)] Predicate devices are produced by Günter Bissinger Medizintechnik Comeg Endoscopy Dufner Instrumente GmbH Henke-Sass Wolf, GmbH Optus, Inc. Pilling Weck Group Wolf Karl Storz Endoscopy and a wide range of other manufacturers
2.7 Device Description: [807.92(a)(4)+(6)]
GIMMI ALPHA Hysteroscopes are comprised of rigid, panoramic telescopes using rod lens technology. The body contact portions are composed of surgical grade stainless steel, which is commonly used in medical devices for a wide range of applications and has a long history of biocompatibility for human use.
Laparoscopic and obstetric-gynecologic accessories are composed of reusable handle and shaft assemblies and removable, reusable tip assemblies. Some specialized instruments, such as the gynecologic fibroid screw and uterine tenaculum are one-piece.
The instruments are designed and manufactured specifically for the purpose of manipulating soft tissue structures (grasping, cutting, dissecting, coagulating and suturing).
2.8 Intended Use: 1807.92 (a)(5)}
GIMMI ALPHA Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.
2
2.9 Industry Standards/Performance Data: [807.92 (d)] GIMMI certifies compliance with relevant ISO/EN/ASTM/
AAMI/ANSI/IEC and other device-related standards that apply to the manufacture, packaging, labeling, and reprocessing of subject devices including the validation of these processes.
2.10 Summary of Testing
All materials used in the composition of GIMMI ALPHA Hysteroscopes and Accessories were subjected to performance and physical tests to evaluate safety, effectiveness, and reliability of the devices. All results were in conformance with the cited harmonized device standards.
2.11 Information Bearing on the Safety and Effectiveness: [807.92 (b)(3)]
The GIMMI "ALPHA Hysteroscopes & Accessories have the same intended use as predicate devices. They are made of the same material and produced to the same international and FDArecognized standards. Slight modifications in design 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/or substantially equivalent to SE devices.
The results of design validation raise no new issues of safety and effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 1 2002
GIMMI GmbH % Mr. Dagmar S. Mäser Business Support International Amstel 320-I, 1017 AP Amsterdam THE NETHERLANDS
Re: K012869
Trade/Device Name: Gimmi Alpha Hysteroscopes & Accessories Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscopes and accessories Regulatory Class: II Product Code: 85 HIH Dated: December 18, 2001 Received: December 20, 2001
Dear Mr. Mäser:
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 recistration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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); 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.
4
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
GIMMI GmbH
510(k) Number Device Name
GIMMI ALPHA® Hysteroscopes & Accessories
INDICATIONS FOR USE
GIMMI ALPHA® Hysteroscopes and Accessories are intended to be used by qualified physicians to provide access, illumination and visualization of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. These generic devices are used to perform diagnostic and surgical procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per CFR 801 109)
OR
V
Over-The-Counter Use _
(Optional Format 1-2-96)
David A. Flynn
(Division Si Division and Ra 510(k) Nun