VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES

K082630 · Zefon Intl. · DXQ · Dec 19, 2008 · Cardiovascular

Device Facts

• Record ID: K082630
• Device Name: VITALCHECK BLOOD PRESSURE CUFF, MODEL ZVC4000 SERIES
• Applicant: Zefon Intl.
• Product Code: DXQ · Cardiovascular
• Decision Date: Dec 19, 2008
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.1120
• Device Class: Class 2

Intended Use

Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

Device Story

Zefon VitalCheck Blood Pressure Cuff, NIBP Tubing & Adapters are reusable accessories designed for use with non-invasive blood pressure (NIBP) monitors. The cuffs wrap around a patient's limb to occlude blood flow, while the tubing and adapters facilitate the pneumatic connection between the cuff and the blood pressure measurement device. These components are used in clinical settings by healthcare professionals to facilitate manual or automatic blood pressure readings. The device does not perform measurements itself but acts as the interface between the patient and the monitoring system, enabling the transmission of pressure signals required for clinical decision-making regarding patient cardiovascular status.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable blood pressure cuffs, tubing, and adapters. Designed for pneumatic connection to NIBP monitors. Materials are consistent with standard medical-grade components for non-invasive blood pressure measurement. No electronic components, software, or energy sources integral to the accessories themselves.

Indications for Use

Indicated for use as reusable accessories with non-invasive automatic or manual blood pressure monitoring systems for patients requiring blood pressure measurement.

Regulatory Classification

Identification

A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.

Submission Summary (Full Text)

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Zefon International c/o Mr. Scott Ryan President 5350 SW 1st Lane Ocala, Florida 34474

DEC 1 9 2008

Re: K082630

Trade/Device Name: Zefon VitalCheck Blood Pressure Cuff. NIBP Tubing and Adapters Regulation Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: Class II (Two) Product Code: DXQ Dated: December 4, 2008 Received: December 5, 2008

Dear Mr. Ryan:

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. 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

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Page 2 - Mr. Scott Ryan

807); labeling (21 CFR Part 801); 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. This letter will allow you to begin marketing your device as described in your Section 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

7 Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Kod 2630 510(k) Number (if known):_

Device Name:

Zefon VitalCheck Blood Pressure Cuff, NIBP Tubing & Adapters

Indications For Use:

Zefon NIPB blood pressure cuffs, tubing & adapters are reusable accessories used in conjunction with non-invasive automatic blood pressure monitors or non-invasive manual blood pressure measurement systems.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH Office of Device Evaluation (ODE) | |
|-------------------------------------------------------|------------------------|
| (Division Sign-Off) | <i>for B Zuckerman</i> |
| | 12/18/08 |
| Division of Cardiovascular Devices | |
| 510(k) Number | K082630 |

| Prescription Use | <b>X</b> | AND/OR | Over-The-Counter Use |
|-----------------------------|----------|--------|------------------------|
| (Part 21 CFR 801 Subpart D) | | | (21 CFR 801 Subpart C) |

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5350 SW 1st Lane Ocala, Florida 34474, USA • Phone: [phone] • Fax: [phone] • www.zefon.com