ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM

K062388 · Docusys · BSZ · Feb 22, 2007 · Anesthesiology

Device Facts

• Record ID: K062388
• Device Name: ANESTHESIA INFORMATION AND DIGITAL-DRUG MANAGEMENT SYSTEM
• Applicant: Docusys
• Product Code: BSZ · Anesthesiology
• Decision Date: Feb 22, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5160
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs. The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes. The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature. Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.

Device Story

Software-based anesthesia information system; integrates physiologic data from patient monitors; enables electronic pre-operative assessment; facilitates drug documentation via manual entry or optional digital-Drug Management System (d-DMS). d-DMS utilizes barcode scanning of Syringe Label Cradles or DocuJect for drug delivery recording. Includes DocuRx pharmacy module for adverse drug event (ADE) screening and narcotics tracking/wasting. Used by anesthesiologists in clinical settings (pre-op, OR, PACU). System standardizes medication administration and documentation; provides clinicians with real-time alerts for potential ADEs; supports billing and record retention.

Clinical Evidence

Clinical testing performed by manufacturer and third-party clinicians in normal operating environments. Study verified software performance and accuracy of data receipt and recording. No specific sensitivity/specificity metrics reported.

Technological Characteristics

Windows-based software application; connects to patient monitors; barcode scanning hardware (Syringe Label Cradle, DocuJect); formulary reference module; pharmacy-managed drug database; supports medication tracking and ADE screening.

Indications for Use

Indicated for use by anesthesiologists for tracking and record keeping of anesthesia procedures, including drug administration, in pre-operative, intra-operative, and PACU settings.

Regulatory Classification

Identification

A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).

Predicate Devices

• PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM (K030939)
• SAFERsleep System (K050883)

Submission Summary (Full Text)

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K062388

FEB 2 2 2007

### 510(k) Summarv

DocuSys Inc. Anesthesia Information and digital-Drug Management System The following information is in accordance with 21 CFR 807.92

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

> DocuSys, Inc. 820 S. University Blvd. Suite 3-H Mobile Al.36609 Tel: [phone] Fax: [phone] Contact Person: Gordon J. Peters, Director Regulatory Compliance Cell [phone]

Date Prepared: May15, 2006

### Name of Device

Anesthesia Information and digital-Drug Management System, DocuSys, Inc.

## Device Classification/Classification Panel

21 C.F.R. 868.5160 Class II Anesthesiology Panel

#### Predicate Devices

- 1) PHILIPS COMPURECORD PERI-OPERATIVE INFORMATION SYSTEM (K030939)
- 2) SAFERsleep System (K050883)

## INTENDED USE

The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.

The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSvs' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed

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to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record. performing ADE checks, and submitting medication utilization information for billing purposes.

The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.

Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.

# DESCRIPTION OF THE DEVICE/SUBSTANTIAL EQUIVALENCE

The DocuSys System is substantially equivalent to the Philips CompuRecord Peri-Operative Anesthesiology Information System. (K030939) and the SAFERsleep System (K050883) marketed by Safer Sleep, LLC.

All three systems are software application programs that run on Windows-based computer systems. The Phillips, Safer Sleep and DocuSys systems are intended for use by anesthesiologists for the tracking and record keeping of anesthesia procedures including the administration of drugs. All three systems can connect electronically to patient monitors that are used during the anesthesia procedure to provide a detailed record of the anesthesia process for record retention and billing purposes.

# PERFORMANCE DATA

The Anesthesia Information and digital-Drug Management System uses currently available technology found in legally marketed devices. Testing was performed at two levels to ensure that the Anesthesia Information and digital-Drug Management System would perform as intended: Non-clinical bench testing to test each function and clinical testing to verify performance of the software. The Anesthesia Information and digital-Drug Management System meets applicable standards for performance and EMC compliance.

### Non-clinical Testing

Testing was performed to evaluate the functional modules.

### Clinical Testing

Clinical testing was performed by DocuSvs and third party clinicians. All values were taken in a normal operating environment. The testing shows that the data was accurately received and recorded.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or other bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2007

Mr. Gordon J. Peters Director Regulatory Compliance DocuSys, Incorporated 820 S. University Boulevard, Suite 3-H Mobile, Alabama 36609

Re: K062388

Trade/Device Name: The Anesthesia Information and Digital-Drug Management System Regulation Number: 21 CFR 868.5160 Regulation Name: Gas Machine for Anesthesia or Analgesia Regulatory Class: II Product Code: BSZ Dated: February 9, 2007 Received: February 16, 2007

Dear Mr. Peters:

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 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 such 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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Page 2 - Mr. Peters

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 Incall that I DA mas made a autes and regulations administered by other Federal agencies. of the Act of ally I oderal statues and spirements, including, but not limited to: registration 1 ou mast conting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and fishing (21 CF R Fart 007), abolity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality of events of Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This telef will anow you to organ mading of substantial equivalence of your device to a premailted 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), n you desire specific at has not of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Qrs

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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# Indications for Use Form

#### 510(k) Number (if known) ____ K062388

Device Name: The Anesthesia Information and digital- Drug Management System Indications for Use:

The DocuSys Anesthesia Information and digital-Drug Management System offers anesthesia a comprehensive record keeping system with advanced patient safety features. The clinician begins interacting with the system through the electronic anesthesia pre-operative assessment in which patient data relative to anesthesia is recorded. Electronic documentation of the patient's allergies and home medications allows for proactive adverse drug event screening when the patient is in the operating room prior to anesthesia delivering drugs.

The DocuSafe electronic anesthesia information system allows the clinician to record anesthesia related events in the pre-op, intra-op, and PACU areas. The DocuSafe software receives physiologic data from various patient monitoring devices. Clinicians enter drug information onto the anesthesia record in one of two methods: a) manually selecting the drug from a list of drugs in the formulary, or b) through the use of DocuSys' optional digital-Drug Management System. If the optional d-DMS is used, the clinician may scan a barcode affixed to a Syringe Label Cradle or use DocuJect to record the drug delivery. A Formulary Reference module, managed by pharmacy, contains drug specific information used for documenting drugs on the anesthesia record, performing ADE checks, and submitting medication utilization information for billing purposes.

The DocuRx pharmacy component of the digital-Drug Management System provides for pre-screening of medications that are ordered by anesthesia to check for any potential adverse drug events. It also provides a methodology for narcotics tracking through its comprehensive medication tracking and wasting feature.

Each component of the Anesthesia Information and digital-Drug Management System plays an integral part in standardizing medication administration techniques and documentation.

Prescription Use X Use OR

Over-The-Counter

(Per 21 C.F.R. 801.109)

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Write May for Husband

Concurrence of CDRH, Office of Device Evalu

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