(84 days)
Not Found
No
The summary describes a standard camera head for endoscopic visualization and does not mention any AI or ML capabilities. The performance studies focus on standard imaging metrics and electrical safety, not AI/ML performance.
No.
The device is used for real-time visualization in diagnostic and surgical procedures, but it does not directly treat or restore health.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for real-time visualization in diagnostic and surgical procedures."
No
The device description explicitly states it consists of an enclosure containing a CMOS image sensor and is connected via cable, indicating it is a hardware device.
Based on the provided information, the KARL STORZ H1 camera head is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "real-time visualization in diagnostic and surgical procedures" by providing images from inside the body. This is a function of an in vivo diagnostic or surgical device, not an in vitro diagnostic device.
- Device Description: The description focuses on capturing images from an endoscope or microscope, which are used to view internal structures of the body. IVD devices typically analyze samples (like blood, urine, tissue) outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory tests.
Therefore, the KARL STORZ H1 camera head is a medical device used for visualization during procedures performed on a living patient (in vivo), not an IVD device which performs tests on samples outside the body (in vitro).
N/A
Intended Use / Indications for Use
The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The camera head consists of an anodized aluminum, stainless steel enclosure containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image sensor that converts light into electrons, the transistors in each pixel then amplify and move the charge using the more traditional wires forming conventional output signals. The camera head is intended to be attached to the proximal end of the endoscopes and is connected via cable to the compatible CCU for power and operational functions. The camera head is designed to be compatible for use with all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for endoscopic observation in general endoscopic procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data: The subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 IEC 62471 ISO 10993 ISO 8600 Performance Testing Color Reproduction and Color Contrast Enhancement Illumination Detection Uniformity Depth of field Spatial Resolution Dynamic Range & Detection Linearity Distortion Latency Signal-to-Noise Ratio (SNR) & Sensitivity Field of View Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the H1 Camera Head has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
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
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
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November 10, 2022
Karl Storz Endoscopy America, Inc. Winkie Wong Manager, Regulatory Affairs 2151 E. Grand Avenue El Segundo, California 90245
Re: K222504
Trade/Device Name: H1 Camera Head Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: GCJ Dated: August 18, 2022 Received: August 18, 2022
Dear Winkie Wong:
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. You must comply with all the Act's
1
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-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222504
Device Name H1 Camera Head
Indications for Use (Describe)
The KARL STORZ H1 camera head, in combination with an appropriately indicated camera control unit (CCU), light source, and monitor, and with an appropriately indicated endoscope, or microscope, is used for real-time visualization in diagnostic and surgical procedures.
Type of Use (Select one or both, as applicable)
| 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 text 'K222504' in a clear, sans-serif font. The text is presented in a single line, with each character distinctly visible. The numbers and letters are evenly spaced, creating a balanced and legible appearance.
Image /page/3/Picture/1 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.
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 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email: Mario.Trujillo@karlstorz.com |
| Date of
Preparation: | August 5, 2022 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: H1 Camera Head
Classification Name: Laparoscope, General & Plastic Surgery
(21 CFR Part 876.1500); |
| Regulatory
Class: | 2 |
| Product Code: | GCJ |
| Guidance
Document: | Not Applicable |
| Predicate
Device: | Predicate device: KSEA CMOS Camera System (C-cam) (K143640). |
| Device
Description: | The camera head consists of an anodized aluminum, stainless steel enclosure
containing a CMOS (Complementary metal-oxide-semiconductor) NTSC image
sensor that converts light into electrons, the transistors in each pixel then amplify
and move the charge using the more traditional wires forming conventional
output signals. The camera head is intended to be attached to the proximal end of
the endoscopes and is connected via cable to the compatible CCU for power and
operational functions. The camera head is designed to be compatible for use with
all standard KARL STORZ Endoscopes, Fiberscopes and Microscope for
endoscopic observation in general endoscopic procedures. |
| Indications For
Use: | The KARL STORZ H1 camera head, in combination with an appropriately indicated
camera control unit (CCU), light source, and monitor, and with an appropriately
indicated endoscope, fiberscope, or microscope, is used for real-time visualization
in diagnostic and surgical procedures. |
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Image /page/4/Picture/0 description: The image shows the alphanumeric string "K222504" in a simple, sans-serif font. The characters are arranged horizontally, with the letter "K" followed by the numbers "222504". The text is black against a white background, creating a clear contrast.
Image /page/4/Picture/1 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 a smaller font.
| Technological
| Characteristics: | Comparison Table: Subject vs. Predicate and Reference Devices | |
|---|---|---|
| Subject Device | Predicate Device | |
| H1 Camera Head | K143650 | |
| KSEA CMOS | ||
| Camera System (C-CAM) | ||
| (B1) Sensor Chip Type | CMOS | Same as subject |
| (B2) Aspect Ratio | 4:3 | Same as subject device |
| (B3) Pixel Count | 1280 x 960 pixels | 168 x 576 pixels |
| (B4) Sensor Resolution | 1280 x 960 | 640 x 480 |
| (B5) Brightness control | Yes | Same as subject device |
| (B6) White Balance | Yes | Same as subject device |
| (B7) Focal Length | 19 mm | 20mm |
| (B8) Compatible CCU | C-HUB | |
| C-MAC III | ||
| Telepack + | C-HUB | |
| C-MAC III | ||
| Non-Clinical | ||
| Performance | ||
| Data: | The subject device follows the FDA recognized consensus standards and is tested | |
| according to the following standards and FDA Guidance: | ||
| Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 IEC 62471 ISO 10993 ISO 8600 Performance Testing Color Reproduction and Color Contrast Enhancement Illumination Detection Uniformity Depth of field Spatial Resolution Dynamic Range & Detection Linearity Distortion Latency Signal-to-Noise Ratio (SNR) & Sensitivity Field of View Additional bench testing was performed to ensure the device met its design | ||
| specifications. The bench testing performed verified and validated that the H1 | ||
| Camera Head has met all its design specification and is substantially equivalent to | ||
| its predicate devices. | ||
| Clinical | ||
| Performance | ||
| Data: | Clinical testing was not required to demonstrate the substantial equivalence to the | |
| predicate devices. Non-clinical bench testing was sufficient to establish the | ||
| substantial equivalence of the modifications. | ||
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that the subject | |
| devices, the H1 Camera Head performs as well as the predicate device. |