(63 days)
The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.
The new autoclavable camera heads are identical to previous single chip and three chip models with the exception that these units are hermetically sealed and use a magnetic switch for operating the integral hand-held camera controls.
The provided text is a 510(k) summary for the Karl Storz Autoclavable Camera Head. It outlines the device's intended use, description, and claims of substantial equivalence to previously reviewed devices. However, it does not contain any information regarding specific acceptance criteria, performance data, or details of a study that proves the device meets such criteria.
The submission focuses primarily on demonstrating substantial equivalence based on the device's design (hermetically sealed, magnetic switch) and sterilization capability, rather than presenting a performance study with detailed metrics.
Therefore, most of the requested information cannot be extracted from this document.
Here's what can be stated based on the provided text:
- Acceptance Criteria and Reported Device Performance: Not provided in the document. The submission focuses on substantial equivalence to predicate devices rather than meeting specific performance metrics.
- Sample size used for the test set and data provenance: Not mentioned. No specific test set or clinical study data is presented.
- Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no test set or ground truth establishment is described.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, an MRMC study is not mentioned.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a camera head, not an AI algorithm.
- The type of ground truth used: Not applicable, as no ground truth is described.
- The sample size for the training set: Not applicable, as no training set for an algorithm is described.
- How the ground truth for the training set was established: Not applicable.
Summary of available information:
The 510(k) summary addresses the regulatory requirements for showing substantial equivalence. It highlights:
- Device Name: Karl Storz Autoclavable Camera Head
- Intended Use: A color, television camera suitable for use with various rigid or flexible endoscopes, coupled to the endoscope, and used with compatible KSI camera control units (CCUs) to display endoscopic images on standard operating room video monitors.
- Device Description: Identical to previous single-chip and three-chip models, but hermetically sealed and uses a magnetic switch for integral handheld camera controls.
- Substantial Equivalence: Claimed to be substantially equivalent to previously reviewed KSI single CCD (K883943) and triple CCD (K950862) camera heads, and in pressurized steam sterilization capability, to M.P. Video's "Autoclaveable Medicam 900 Digicon Camera" (K942358).
The document's purpose is to demonstrate that the new autoclavable camera head is safe and effective because its technological characteristics and intended use are comparable to legally marketed predicate devices, not through a detailed performance study with specific acceptance criteria and outcome data.
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510(k) Summary of Safety and Effectiveness
This summary of premarket notification 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.
| Application: | Karl Storz Imaging, Incorporated175 Cremona DriveGoleta, California 93117 | ||
|---|---|---|---|
| Contact: | Mr. Terry Fernandez | ||
| Registration: | 2027009 | ||
| Device Name: | Proprietary Name -- Karl Storz Autoclavable Camera HeadCommon Name -- Color Television Camera HeadClassification Name -- Camera, Television, Endoscopic | ||
| Intended Use: | The Karl Storz Imaging (KSI) Autoclavable camera head is a color, televisioncamera. suitable for use with any rigid or flexible endoscope, including, but notlimited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes,gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopesand arthroscopes. The camera head is coupled to the endoscope. The camerahead may be used with any current, compatible KSI camera control unit(CCU). The endoscopic image can then be displayed on any standard operatingroom video monitor. | ||
| Device Description: | The new autoclavable camera heads are identical to previous single chip andthree chip models with the exception that these units are hermetically sealedand use a magnetic switch for operating the integral hand-held camera controls. | ||
| Substantial Equivalence: | KSI Autoclavable Camera Heads are substantially equivalent to previouslyreviewed KSI single CCD (charge coupled device) and triple CCD cameraheads and, in pressurized steam sterilization capability, to M.P. VideoAutoclaveable Camera Heads. KSI's proposed new camera heads and theirindications for use are based upon KSI's premarket notification numbers,K883943 (single chip) and K950862 (three chip), and its autoclavability basedupon M.P. Video's "Autoclaveable Medicam 900 Digicon Camera",premarket notification number K942358. | ||
| Signed: | Terry Fernandez | Date: | 1/31/00 |
| 1/31/00 |
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DEPARTMENT OF E
4 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Terry Fernandez Director, Regulatory and Standards Compliance Karl Storz Imaging, Inc. 175 Cremona Drive Goleta, CA 93117
Re: K994090
KSI Autoclavable Camera Head Dated: December 2, 1999 Received: December 3, 1999 Regulatory Class: Il 21 CFR §876.1500/Procode: 78 KOG
Dear Mr. Fernandez:
1 B
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
CART David S. Schulte, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 0001 | C( | ||
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| Marketof the consumer of the first a |
510(k) Number (if known):
Device Name: KSI AUTOCLAVABLE CAMERA HEAD
Indication for Use:
The Karl Storz Imaging (KSI) Autoclavable camera head is a color, television camera. suitable for use with any rigid or flexible endoscope, including, but not limited to sinoscopes, colonoscopes, sigmoidoscopes, bronchoscopes, gastroscopes, laparoscopes, choledochoscopes, ureteroscopes, hysteroscopes and arthroscopes. The camera head is coupled to the endoscope. The camera head may be used with any current, compatible KSI camera control unit (CCU). The endoscopic image can then be displayed on any standard operating room video monitor.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
0000021
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
510(k) Number
Prescription Use
(Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K994090 |
|---|---|
| --------------- | --------- |
§ 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.