(91 days)
Not Found
Not Found
No
The description focuses on the physical components and intended use of a rigid endoscope, with no mention of AI/ML capabilities, image processing, or related performance metrics.
No
The device is described as an endoscope for visual examination and diagnostic or operative procedures, not for treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is used to "perform diagnostic and operative procedures" and lists numerous conditions for which it is indicated, such as "Unexplained pelvic pain," "Menstrual abnormalities," "Infertility and sterility," and "Indefinite pelvic mass," all of which imply a diagnostic purpose.
No
The device description explicitly states it is comprised of a rigid, panoramic telescope and tubular stainless steel components, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body. The intended use and device description clearly state that the Transvaginal Endoscope (TVE) is used for direct visualization within the female genital tract (vagina, cervix, uterus, fallopian tubes, ovaries). It provides video visual access for examination and procedures performed in situ.
- The device description focuses on the physical components for visualization. It describes a rigid telescope and stainless steel components, which are typical of endoscopic devices used for direct internal examination.
- There is no mention of analyzing biological samples. The indications for use describe conditions and procedures that are diagnosed and performed through direct visual inspection and potentially biopsy (which is a procedure to obtain a sample, not the analysis of the sample itself by this device).
Therefore, the Transvaginal Endoscope is an in vivo diagnostic and operative device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indication: The Transvaginal Endoscope (TVE) and Accessories are indicated for use to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures.
Specific Indications for Use
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility; .
- Indefinite pelvic mass; .
- Ectopic pregnancy; ●
- . Pelvic endometriosis;
- Polycystic ovaries: .
- . Pelvic inflammatory disease (PID);
- . Pain mapping:
- Congenital abnormalities of the pelvic organs; .
- Lysis of adhesions: .
- Cytology mapping; .
- . Biopsy.
Indications for Use: The TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. Indications for use are:
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility: .
- . Indefinite pelvic mass;
- Ectopic pregnancy; .
- Pelvic endometriosis; .
- Polycystic ovaries: .
- Pelvic inflammatory disease (PID); ●
- Pain mapping: ●
- . Congenital abnormalities of the pelvic organs:
- Lysis of adhesions; .
- Cytology mapping: .
- Biopsv. .
Product codes (comma separated list FDA assigned to the subject device)
85 HEW
Device Description
The Transvaginal Endoscope Set is comprised of a rigid, panoramic telescope, which utilizes rod lens technology, and several tubular stainless steel components. The body contact portions of the components are manufactured from 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
video visual access
Anatomical Site
vagina, cervix, uterus, fallopian tubes, ovaries, female genital tract, pelvic organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified surgeons during outpatient or clinical endoscopic examination
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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.
Not Found
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
§ 884.1640 Culdoscope and accessories.
(a)
Identification. A culdoscope is a device designed to permit direct viewing of the organs within the peritoneum by a telescopic system introduced into the pelvic cavity through the posterior vaginal fornix. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include trocar and cannula, instruments used through an operating channel, scope preheaters, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for culdoscope 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 culdoscope accessory instruments include: lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable) scissors, and suction/irrigation probe. 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
FEB 27 2004
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information 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.
| Applicant: | Karl Storz Endoscopy - America, Inc.
600 Corporate Pointe Drive
Culver City, CA 90230
310-338-8100 |
|------------------------|-------------------------------------------------------------------------------------------------------------|
| Contact: | Yvonne Fernandez
Senior Regulatory Affairs Specialist
310-348-4226 |
| Device Identification: | Common Name: Transvaginal Endoscope and Accessories |
Indication: The Transvaginal Endoscope (TVE) and Accessories are indicated for use to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures.
Specific Indications for Use
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility; .
- Indefinite pelvic mass; .
- Ectopic pregnancy; ●
- . Pelvic endometriosis;
- Polycystic ovaries: .
- . Pelvic inflammatory disease (PID);
- . Pain mapping:
- Congenital abnormalities of the pelvic organs; .
- Lysis of adhesions: .
- Cytology mapping; .
- . Biopsy.
Device Description: The Transvaginal Endoscope Set is comprised of a rigid, panoramic telescope, which utilizes rod lens technology, and several tubular stainless steel components. The body contact portions of the components are manufactured from 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.
Substantial Equivalence: The Transvaginal Endoscope Set is substantially equivalent to the predicate device since the basic features, design, and intended uses are the same. The minor differences between the Transvaginal Endoscope Set and the predicate device raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices.
Signed:
Yvonne Fernandez/Senior Regulatory Affairs Specialist
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle symbol, with three curved lines representing the eagle's body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2004
Ms. Yvonne Fernandez Senior Regulatory Affairs Specialist Karl Storz, Endoscopy-America, Inc. 600 Corporate Pointe, 5th Floor CULVER CITY CA 90230-7600
Re: K033728
Trade/Device Name: Transvaginal Endoscopy (TVE) Set Regulation Number: 21 CFR 884.1640 Regulation Name: Culdoscope and accessories Regulatory Class: II Product Code: 85 HEW Dated: November 18, 2003 Received: December 1, 2003
Dear Ms. Fernandez:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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,
2
Page 2
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 yours,
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
3
Indications for Use
| 510(k) Number (if known): | K033728 |
|---|---|
| Device Name: | Transvaginal Endoscopy Set |
Indications for Use: The TVE Set is indicated for use by qualified surgeons during outpatient or clinical endoscopic examination of the female genital tract. This examination method is designed to provide video visual access for endoscopic examination of the vagina, cervix and uterus, and through transvaginal access, allow visualization of both fallopian tubes and the ovaries to perform diagnostic and operative procedures. Indications for use are:
- Unexplained pelvic pain (acute, chronic) .
- . Menstrual abnormalities;
- Infertility and sterility: .
- . Indefinite pelvic mass;
- Ectopic pregnancy; .
- Pelvic endometriosis; .
- Polycystic ovaries: .
- Pelvic inflammatory disease (PID); ●
- Pain mapping: ●
- . Congenital abnormalities of the pelvic organs:
- Lysis of adhesions; .
- Cytology mapping: .
- Biopsv. .
Prescription Use AND/OR Over-The-Counter Use x (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Brogdon
vision of Reproductive, Abdom and Radiological De 510(k) Number