(261 days)
Not Found
No
The device description focuses on optical technology and rigid telescopes, with no mention of AI, ML, image processing, or data sets typically associated with AI/ML applications.
No.
The device is used for viewing the cervical and uterine cavity for diagnostic and surgical procedures, but it does not directly perform or facilitate a therapeutic action itself; it's a viewing tool.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended for "viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures."
No
The device description explicitly states it is a rigid telescope utilizing rod lens technology and optical glass rods, which are physical hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The HOPKINS Telescopes are used for direct viewing of the cervical and uterine cavity within the body ("in vivo"). They are used for diagnostic and surgical procedures performed directly on the patient.
- Lack of Specimen Testing: The description does not mention any testing of biological specimens. The device's function is to provide visual access to internal anatomy.
Therefore, based on the provided information, the HOPKINS Telescopes are a surgical/endoscopic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
HIH
Device Description
The HOPKINS Telescopes are rigid telescopes that utilize the rod lens technology. At the distal end of the telescope's shaft is the lens and the other end of the shaft is attached to the eyepiece. Throughout the central lumen of the HOPKINS Telescopes, optical glass rods are used to transmit and magnify the image received from the lens. The HOPKINS Telescopes are available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm diameter and 26cm, 30cm, 36cm working lengths.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cervical canal, uterine cavity
Indicated Patient Age Range
Adults
Intended User / Care Setting
Hospital
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)
Comparative bench testing between the subject and predicate device demonstrated that the HOPKINS Telescopes has met all its design specification and is substantially equivalent to its predicate device.
Clinical studies were not required to demonstrate substantial equivalence to the predicate device.
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.
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
§ 884.1690 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/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 14, 2023
Karl Storz Endoscopy America, Inc. Jordan Lydia Verla Senior Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K223885
Trade/Device Name: HOPKINS Telescopes Regulation Number: 21 CFR§ 884.1690 Regulation Name: Hysteroscope and Accessories Regulatory Class: II Product Code: HIH Dated: August 28, 2023 Received: August 29, 2023
Dear Jordan Lydia Verla:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jason Roberts -S
Jason R. Roberts, Ph.D. Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223885
Device Name HOPKINS Telescopes
Indications for Use (Describe)
The HOPKINS Telescopes when used with sheaths are intended to be used to permit viewing of the cervical and uterine cavity for the purpose of performing diagnostic and surgical procedures.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
7. 510(k) Summary
This 510(k) Summary 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.
| Submitter: | KARL STORZ Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo, CA 90245 |
|---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jordan Lydia Verla
Senior Regulatory Affairs Specialist
Tel: (424) 218-8100 ext. 8382
Email: Jordan.Verla@karlstorz.com |
| Date of
Preparation: | September 11, 2023 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: HOPKINS Telescopes
Classification Name: Hysteroscope and accessories (21 CFR 884.1690) |
| Regulatory Class: | II |
| Product Code: | HIH |
| Classification
Panel: | Obstetrics/Gynecology |
| Predicate
Device(s): | KARL STORZ Magnifying Hysteroscopes (K935716)
The predicate device has not been subject to a design-related recall. |
| Device
Description: | The HOPKINS Telescopes are rigid telescopes that utilize the rod lens
technology. At the distal end of the telescope's shaft is the lens and the
other end of the shaft is attached to the eyepiece. Throughout the central
lumen of the HOPKINS Telescopes, optical glass rods are used to transmit
and magnify the image received from the lens. The HOPKINS Telescopes are
available with 0°, 12° and 30° direction of view, 2mm, 2.9mm, 4mm
diameter and 26cm, 30cm, 36cm working lengths. |
| Intended Use and
Indications for
Use: | Intended Use:
The HOPKINS Telescopes in conjunction with the sheath are intended to be
used to permit viewing of the cervical canal and uterine cavity for the
purpose of performing diagnostic and surgical procedures. |
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.
| Technological
Characteristics: | Indications for Use:
The HOPKINS Telescopes when used with sheaths are intended to be used
to permit viewing of the cervical and uterine cavity for the purpose of
performing diagnostic and surgical procedures.
The subject and predicate devices have similar indications for use, operating
principle, and similar technological characteristics. | | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | HOPKINS Telescopes
Subject Device | Magnifying Hysteroscopes
Predicate Device K935716 | |
| | Indications
for Use | The HOPKINS Telescopes when
used with sheaths are intended to
be used to permit viewing of the
cervical and uterine cavity for the
purpose of performing diagnostic
and surgical procedures. | I. Diagnostic Hysteroscopy
A. Indications for Use Abnormal uterine
bleeding Infertility and pregnancy
wastage Evaluation of abnormal
hysterosalpingogram Intrauterine foreign body Pelvic pain B. Absolute Contraindications
for Use Acute Pelvic Inflammatory
Disease (PID) C. Relative Contraindications
for Use Inability to distend uterus Cervical/vaginal infection Uterine bleeding or
menses Known pregnancy Invasive carcinoma of the
cervix Recent uterine
perforation Medical contraindication Intolerance to anesthesia D. Warnings Suspicion of pregnancy
should suggest a |
| | | | |
| | | performance of diagnostic | |
| | | hysteroscopy. | |
| | E. | Precautions | |
| | | • Vaginal ultrasonography | |
| | | prior to hysteroscopy may | |
| | | identify clinical conditions | |
| | | that will alter patient | |
| | | management. | |
| | F. | Operative Hysteroscopy | |
| | | A.Indications for Use | |
| | | • Directed biopsy | |
| | | • Removal of submucuous | |
| | | fibroids and large polyps | |
| | | • Submucosous | |
| | | myomectomy | |
| | | • Transection of | |
| | | intrauterine adhesions | |
| | | • Transection of | |
| | | intrauterine septa | |
| | | • Endometrial ablation | |
| | | B. Absolute | |
| | | Contraindications for Use | |
| | | • Acute PID | |
| | | C. Relative Contraindications | |
| | | for Use | |
| | | • Inability to distend uterus | |
| | | • Cervical/vaginal infection | |
| | | • Uterine bleeding or | |
| | | menses | |
| | | • Known pregnancy | |
| | | • Invasive carcinoma of the | |
| | | cervix | |
| | | • Recent uterine | |
| | | perforation | |
| | | • Medical contraindication | |
| | | • Intolerance to anesthesia | |
| | | D.Relative Contraindications | |
| | | to Endometrial Ablation | |
| | | • Hysteroscopic | |
| | | endometrial ablation, | |
| | | whether by laser or | |
| | | electrosurgery, should not | |
| | | be undertaken before | |
| | | | |
| | | adequate training,
preceptorship and clinical
experience. Additionally,
tissue sampling is required
prior to destruction of the
endometrium. The
following are clinical
conditions that can
significantly complicate
hysteroscopic endometrial
ablation:
• Adenomatous
endometrial
hyperplasia
• Severe adenomyosis
• Pelvic pain (subtle
PID)
• Uterine anomalies
E. Relative Contraindications
to Hysteroscopic
Myomectomy
• Hysteroscopic
myomectomy,
whether by laser or
electrosurgery,
should not be
undertaken before
adequate training,
preceptorship and
clinical experience.
The following are
clinical conditions
that can significantly
complicate
hysteroscopic
myomectomy:
Severe anemia
Inability to
circumnavigate
the myoma
F. Warnings | |
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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
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Image /page/6/Picture/0 description: The image contains the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters at the top of the logo. Below that, in smaller blue letters, is the phrase "KARL STORZ - ENDOSKOPE". The logo is simple and professional.
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Image /page/7/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| Product
| Code(s) | HIH | HIH |
|---|---|---|
| Target | ||
| Population | Adults | Adults |
| Anatomical | ||
| site | Cervical canal, uterine cavity | Cervical canal, uterine cavity |
| Where used | Hospital | Hospital |
| Endoscope | ||
| Type | Rigid, rod lens | Rigid, rod lens |
| Distal Tip | ||
| Diameter | Scope: 2mm, 2.9mm, 4mm | |
| Sheaths: 2.3mm-8mm | Scope: 2.7mm, 2.9mm, 4mm | |
| Working | ||
| Length | Scope: 26cm, 30cm, 36cm | Scope: 18cm, 30cm |
| Direction of | ||
| View | 0°, 12°, 30° | 30° |
| Field of View | 79°, 59°, 88°, 82°, 86°, 62° | |
| (laboratory | ||
| measurement) | 82°, 60°, 68°, 68°, 51°, 81° | |
| Depth of Field | 0mm-362mm | 5mm-302mm |
| Light Source | External | External |
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Image /page/8/Picture/0 description: The image shows the logo for STORZ, a company that specializes in endoscopes. The word "STORZ" is written in large, bold, blue letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE", also written in blue. The logo is simple and professional, and it effectively communicates the company's name and focus.
| | Patient-
Contacting
Material | | |
|--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------|
| | | Scopes: Surgical Stainless Steel
Sheaths: Surgical Stainless Steel
Bridges: Surgical Stainless Steel | Chromium Plated Monel 400 |
| | Cleaning | Manual, Automatic | Manual |
| | Sterilization | Scopes:
Steam (pre-vacuum),
STERRAD 100NX, STERRAD
NX, STERRAD 100S, STERIS
V-PRO | EO Sterilization |
| | | Trophyscope:
Steam (pre-vacuum),
STERRAD 100NX, STERIS V-
PRO | |
| | | Bridges:
Steam (pre-vacuum) | |
| | | Sheaths:
Steam (pre-vacuum) | |
| Non-Clinical
Performance
Data: | There are no performance standards or special controls developed under
Section 514 of the FD&C Act for endoscopes. However, the HOPKINS
Telescopes follows the FDA recognized consensus standards and is tested
according to the following standards and FDA Guidance: | | |
| | FDA Guidance | | |
| | ● Hysteroscopes and Gynecology Laparoscopes - Submission Guidance
for a 510(k) | | |
| | ISO Endoscopic Standards | | |
| | ● ISO 8600-1 | | |
| | ● ISO 8600-3 | | |
| | ● ISO 8600-5 | | |
| | ● ISO 8600-6 | | |
| | Biocompatibility Summary | | |
| | ● Cytotoxicity (ISO 10993-5) | | |
| | ● Acute Systemic Toxicity (ISO 10993-11) | | |
| | ● Intracutaneous Irritation (ISO 10993-10) | | |
| | ● Maximization Sensitization (ISO 10993-10) | | |
| | Electrical Safety and EMC | | |
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Image /page/9/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and consists of the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller, less bold letters.
| IEC 60601-2-18 (3RD Edition) | |
|---|---|
| Reprocessing (Cleaning and Sterilization) AAMI TIR12: 2010 AAMI TIR30: 2011 ANSI/AAMI ST8: 2013 ANSI/AAMI ST77:2013 ANSI/AAMI ST79:2017 ANSI/AAMI ST81:2004/(R)2010 AAMI/ISO 14937:2009 ANSI/AAMI/ISO 17655-1:2006/2013 Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling | |
| Clinical | |
| Performance | |
| Data: | Comparative bench testing between the subject and predicate device demonstrated that the HOPKINS Telescopes has met all its design specification and is substantially equivalent to its predicate device. |
Clinical studies were not required to demonstrate substantial equivalence to the predicate device. |
| Conclusion: | The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device to support a substantial equivalence determination. |