(90 days)
Not Found
Not Found
No
The summary describes a hardware interface controller for connecting existing devices and does not mention any AI/ML capabilities or related performance metrics.
No
The device is described as an interface controller that connects other devices to a communication bus; it does not directly treat or diagnose a medical condition.
No
The device is described as an interface controller that connects devices to a communication bus. Its purpose is to facilitate communication and control, not to diagnose medical conditions or analyze patient data for diagnostic purposes.
No
The summary explicitly mentions "hardware/software validations procedures" and "Data included in this submission demonstrate the safety and effectiveness of the SCB Computer Motion Interface Controller," implying the device includes hardware components that were validated.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to connect devices to a communication bus (SCB) for control purposes, specifically related to a voice-control system. This is a technical interface function, not a diagnostic one.
- Device Description: The description reinforces its role as an interface controller for connecting devices.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting diseases, or providing diagnostic information.
- No Image Processing, AI/ML, or Imaging Modality: These are often associated with diagnostic devices, and their absence further supports that this is not an IVD.
- Performance Studies: The performance studies mentioned are focused on safety and effectiveness through hazard analyses and hardware/software validations, which are typical for medical devices but not specifically indicative of an IVD's performance metrics (like sensitivity, specificity, etc.).
In summary, the SCB Computer Motion Interface Controller is a technical interface device designed to facilitate communication and control between different medical devices. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.
Product codes (comma separated list FDA assigned to the subject device)
GCJ
Device Description
The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.
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)
Hazard analyses and hardware/software validations procedures were provided in this submission.
Data included in this submission demonstrate the safety and effectiveness of the SCB Computer Motion Interface Controller.
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
§ 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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JUN - 5 2003
an 1 of V
SCB Computer Motion Interface Controller 510(k) Summary
In accordance with 21 CFR section 807.92 Computer Motion, Inc. (CMI) is submitting the following 510(k) Summary:
1) Submitter Information
Computer Motion. Inc. 130-B Cremona Drive Goleta, CA 93117
Contact: Cathy Stupak, Ph.D.
2) Name of Device:
| Proprietary Name: | SCB Computer Motion Interface Controller |
|---|---|
| Common Name: | n/a |
| Classification Name: | Laparoscope, General & Plastic Surgery |
| Regulation Number: | 876.1500 |
| Product Code: | GCJ |
| Class: | Class II. |
3) Substantial Equivalence:
This submission establishes the substantial equivalence of the SCB Computer Motion Interface Controller to Computer Motion's HERMES® Port Expander
4) Description of the Device:
The SCB Computer Motion Interface Controller (SCIC) connects devices that are controlled by Computer Motion's voice-control system to the Storz Communication Bus (SCB) manufactured by Karl Storz.
| Test | Title |
|---|---|
| IEC 601-1 | International Standard for Medical |
| Electrical Equipment | |
| IEC 601-1-1 | International Standard for Medical |
| Electrical Equipment | |
| IEC 601-2-18 | International Standard for Medical |
| Electrical Equipment | |
| UL 2601-1 | Underwriters Laboratory |
The SCIC is tested to the following standards:
continued
1
/ C 3 0 7 / EONFIDENTIAL Pg 2 of 2
| Test | Title |
|---|---|
| EN55011/A1 CISPR 11 | Conducted Emission |
| EN55011/A1 CISPR11 | Radiated Emission |
| EN61000-4-2 | Electrostatic Discharge |
| EN61000-4-3 and EN50140 | RF Immunity |
| EN61000-4-4 | EFT/Bursts Immunity |
| EN61000-4-5 | Surge Immunity |
| EN61000-4-6 | Conducted Immunity |
| EN60601-1 | International Standard for Medical |
| Electrical Equipment | |
| EN60601-1-1 | General Requirements for Safety - |
| Collateral Standard | |
| EN 60601-1-2 | Emissions and Immunity Test |
| Measurements | |
| CAN/CSA-C22.2 No. 601.1 | Medical Electrical Equipment Part 1, |
| General Requirements for Safety, General | |
| Instructions Part 1 | |
| VA-19795 | CMI Environmental Testing |
5) Intended Use
The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.
6) Technological Characteristics in Comparison to the Predicate
The predicate, the HERMES Port Expander, is an extension of the HERMES O.R. Control Center, providing 8 additional device connection ports for devices, whereas the SCIC is an extension of the Storz SCB, providing 8 additional device connection ports for devices.
8) Device Testing
Hazard analyses and hardware/software validations procedures were provided in this submission.
9) Conclusion drawn from the Device Testing
Data included in this submission demonstrate the safety and effectiveness of the SCB Computer Motion Interface Controller.
2
Image /page/2/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" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 5 2003
Mr. Keith Lowrey Regulatory Affairs Manager Computer Motion, Inc. 130-B Cremona Drive GOLETA CA 93117
Re: K030718
Trade/Device Name: SCB Computer Motion Interface Controller Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: 78 GCJ Dated: March 6, 2003 Received: March 7, 2003
Dear Mr. Lowrey:
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 fegistration, 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 (OS) 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 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 this 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" (21 CFR Part 807.97). 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 Brogdon
Nancy C. Brogdon
Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
CONFIDENTIAL
INDICATION FOR USE STATEMENT
Ko30718 510(k) Number (if known): _
Device Name: SCB Computer Motion Interface Controller
The SCB Computer Motion Interface Controller is indicated for use with the Storz Communication Bus (SCB) manufactured by Karl Storz to connect HERMES-Ready™ devices to the SCB.
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CRDH, Office of Device Evaluation (ODE)
Prescription Use (per 21 CFR 801.109)
OR
Over-the-Counter Use (Optional Format 1-2-96)
":
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices h10(k) Number
000023