(95 days)
No
The document describes a rigid endoscope with a rod-lens system, similar to existing devices, and makes no mention of AI, ML, image processing, or any related concepts.
No.
The device functions as a visualization tool to assist in diagnostic and surgical procedures, but it does not directly treat or provide therapy itself. It is an instrument used during therapeutic procedures, but not a therapeutic device in its own right.
Yes
The "Intended Use / Indications for Use" section explicitly states that both the hysteroscope and gynecologic laparoscope are used "for the purpose of performing diagnostic and surgical procedures," indicating their role in diagnosing conditions.
No
The device description explicitly details physical components like an eyepiece, body, light guide, rod-lens system, and surgical steel tubes, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the asap endoscope is a rigid endoscope used for direct visualization of internal anatomical sites (cervical canal, uterine cavity, peritoneal cavity) for the purpose of performing diagnostic and surgical procedures. It provides illumination and visualization, not analysis of specimens taken from the body.
- Lack of IVD Characteristics: The description does not mention any components or functions related to collecting, preparing, or analyzing biological specimens. There is no mention of reagents, assays, or any other elements typically associated with IVD devices.
Therefore, the asap hysteroscope and gynecologic laparoscope are considered surgical endoscopes, not IVDs.
N/A
Intended Use / Indications for Use
Hysteroscope: Provides illumination and visualization of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
Gynecologic Laparoscope: Used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Product codes
85 HIH, 85 HET
Device Description
The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cervical canal, uterine cavity, peritoneal 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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Baho Hysteroscope (K # not available), Galileo hysteroscope (K962256), Baho Gyn. Laparoscope (K982276)
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
510/k) Summary of safety and effectiveness
Applicant:
SEP 2 9 2003
asap endoscopic products GmbH Tullastr. 87 a 79108 Freiburg / Germany
Contact:
Dr. Martina Günderoth C.R.C. Partnerschaftsgesellschaft Katharinenstr. 5 23554 Lübeck, Germany
Phone: +49 (451) 388 2864 Fax: +49 (451) 388 2867 Email: crc@crc-online.de
Device name
| Hysteroscope, Types: | 10-0018-00, 10-0019-00, 10-0020-00, 10-0021-00,
10-0022-00, 10-0023-00, 10-0024-00, |
|-------------------------|----------------------------------------------------------------------------------------|
| Gyn. Laparoscope, Types | 10-0015-00, 10-0016-00, 10-0089-00, |
Common name
Hysteroscope, Gyn. Laparoscope
Predicate device name
- Baho Hysteroscope (K # not available) and Galileo hysteroscope (K962256)
- Baho Gyn. Laparoscope (K982276)
Code of Federal Regulations (CFR) number
888.1690 and 884.1720
General device description
The asap hysteroscope and gynecologic laparoscope (herinafter: asap endoscope) is a rigid type endoscope with a new generation of compact objectives and a newly developed rod-lens system.
The basic design of the asap endoscope is similar to those legally available for sale in the U.S.A.. It consists of an eyepiece and the body with light guide and rod-lens system. The body is designed of an outer and an inner tube of surgical steel. The light carrying fibers are sandwiched between these tubes. The inner tube of the body contains the rod-lens system.
1
510(k) Sum
Indications for use
Like the predicate device, the asap hysteroscope is used to illuminate and visualize the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.
The asap gynecologic laparoscope is - like the predicate device - used to permit direct viewing of the organs wihin the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.
Voluntary standard compliance
The asap endoscopse comply with
-
applicable portions of voluntary standards IEC 60601-2-18
-
DIN 58105, part 1 and 2
-
DIN 17442 (medical steel), as well as applicable portions of
-
DIN 980
Substantially equivalence - Safety and effectiveness
The specifications and intended use of the asap endoscopes are the same to those of the claimed predicate devices. There are no significant differences between the asap endoscopes and the claimed predicates in design or conditions of intended use.
The asap endoscope is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility. The asap endoscope conforms to applicable ISO standards.
The device will be sold non-sterile, to be sterilized prior to each procedure by the user. The ability to repeatedly adequately sterilize the devices has been confirmed by validation protocol.
Conclusion
In all respects, the asap endoscope is substantially equivalent to one or more rigid endoscopes currently marketed in the USA. It is constructed of materials of the same specifications as the predicate devices to ensure biocompatibility and it conforms to applicable ISO standards.
The ability to repeatedly adequately sterilize the asap endoscopes has been confirmed by validation protocol.
2
Image /page/2/Picture/1 description: The image is a black and white seal. The seal is circular and contains text around the perimeter. The text reads "Department of Health & Human Services USA". In the center of the seal is an abstract image of an eagle.
SEP 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Horst Baholzer General Manager asap endoscopic products GmbH Tullastr. 87a 79108 freiburg GERMANY
Re: K031974
Trade/Device Name: asap Hysteroscope, Models 10-0018-00, 10-0019-00, 10-0020-00, 10-0021-00, 10-0022-00, 10-0023-00, 10-0024-00; and, asap Gynecologic Laparoscope (Surgery), Models 10-0015-00, 10-0016-00, and 10-0089-00 Regulation Number: 21 CFR §884.1690 Regulation Name: Hysteroscope and accessories
Product Code: 85 HIH Regulation Number: 21 CFR §884.1720 Regulation Name: Gynecologic laparoscope and accessories
Product Code: 85 HET
Regulatory Class: II
Dated: June 10, 2003
Received: July 1, 2003
Dear Mr. Baholzer:
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 de vices 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.
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.
3
This letter will allow you to begin marketing your device as described in your Section 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 the 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" (21CFR Part 807.97) you may obtain. 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 vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):_______K031974
Device Name:
Indications For Use:
Hysteroscope: Provides illumination and visualization of the cervical canal and the r frorerosevity for the purpose of performing diagnostic and surgical procedures.
Gynecologic Laparoscope: Used to permit direct viewing of the organs within the Cyrioosie Laparess a performing 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)
Daniel h. Inson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev
510(k) Number K031974
Prescription Use
(Per 21 CFR 801.109)
(Optional Format 3-10-98)