(81 days)
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 (BISx Module 91482) is an easy-to-use, slim, single module in the Spacelabs Medical family of Spacelabs Medical Ultraview System (Ultraview) modules. The BISx Module 91482 is a microprocessor based, two-channel EEG unit designed for use on adult and pediatric patients within a hospital or medical facility. Its system configuration includes the BISx Module 91482 with connectors for external serial data connections, a BISx pod, a patient interface cable, disposable sensors, and printer options. The BISx pod, patient interface cable and disposable sensors are manufactured by Aspect Medical Systems, and distributed by Spacelabs Medical for use with the BISx Module 91482, The Spacelabs Medical Ultraview monitor provides the display capabilities for the care provider.
The provided text describes the Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482, but it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.
The document is a 510(k) Premarket Notification summary focusing on the general safety and effectiveness, device description, and indications for use as part of the FDA approval process. It confirms substantial equivalence to existing devices but does not detail device performance studies or their results.
Therefore, I cannot populate the requested table or answer the specific questions about the study that proves the device meets acceptance criteria based solely on the provided text. The requested information, such as sample sizes, ground truth establishment, expert qualifications, and specific performance metrics, is not present in this document.
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510(k) Premarket Notification K060900 Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 and Accessories Summary of Safety and Effectiveness
May 15, 2006
The SIO(k) summary of safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 1992.
| Subject: | 510(k) Summary of Safety and Effectiveness Information for the SpacelabsMedical Bispectral Index (BISx) Analysis Module 91482 |
|---|---|
| Submitter: | Spacelabs Medical, Inc.PO Box 7018Issaquah, WA 98029 |
| David J. GeraghtyPhone: 1 425 657 7200Fax: 1 425 657 7207david.geraghty@slmd.com | |
| ProprietaryName: | Spacelabs Medical Bispectral Index (BISx) Analysis Module, model 91482 |
| CommonName andClassification: | Electroencephalograph (EEG) Monitor(84 GWQ, §882.1400, Class II) |
| DeviceDescription: | The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482(BISx Module 91482) is an easy-to-use, slim, single module in the SpacelabsMedical family of Spacelabs Medical Ultraview System (Ultraview) modules.The BISx Module 91482 is a microprocessor based, two-channel EEG unitdesigned for use on adult and pediatric patients within a hospital or medicalfacility. Its system configuration includes the BISx Module 91482 withconnectors for external serial data connections, a BISx pod, a patient interface |
cable, disposable sensors, and printer options. The BISx pod, patient interface cable and disposable sensors are manufactured by Aspect Medical Systems, and distributed by Spacelabs Medical for use with the BISx Module 91482, The Spacelabs Medical Ultraview monitor provides the display capabilities for the
BISx Summary of Safety and Effectiveness Addendum to 510(k), K060900
care provider.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The department's name is written in a circular fashion around the eagle. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spacelabs Medical Inc. c/o Mr. David J. Geraghty Manager, Regulatory and Quality P.O. Box 7018 Issaquah, Washington 98027
APR - 9 2012
Re: K060900
Trade/Device Name: Spacelabs Medical Bispectral Index (BIS) Analysis Module 91482 and Accessories
Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, OLT, ORT Dated (Date on orig SE ltr): May 23, 2006 Received (Date on orig SE Itr): May 25, 2006
Dear Mr. Geraghty:
This letter corrects our substantially equivalent letter of June 23, 2006.
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 (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 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.
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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
文
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
KOGO900
510(k) Number (if known):
Device Name:
Indications for Use:
Spacelabs Medical Bispectral Index (BIS) Analysis Module 91482, and Accessories
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. It is intended for use on adult and pediatric patients within a hospital or medical facility providing patient care to monitor the state of the brain by data acquisition of EEG signals.
The Spacelabs Medical Bispectral Index (BISx) Analysis Module 91482 may be used as an aid in monitoring the effects of certain anesthetic agents. Use of BIS monitoring to help guide anesthetic administration may be associated with the reduction of the incidence of awareness with recall in adults during general anesthesia and sedation.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR Over-The-Counter Use
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH2 Office of Device Evaluation (ODE)
Helmut Werner
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
Ko 60900 510(k) Number.
Page 1 of 1
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).