HM-LAMP II

K100234 · Hillusa, Inc. · FTD · Jul 8, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100234
• Device Name: HM-LAMP II
• Applicant: Hillusa, Inc.
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jul 8, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2

Intended Use

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Device Story

HM-LAMP II Series are surgical lamps featuring a flexible movement arm and mobile stand. Designed for use in operating rooms or clinical settings to provide visible illumination of the surgical field or patient during minor surgical procedures. Operated by healthcare professionals. Device provides illumination; no complex data processing or clinical decision support involved.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Surgical lamp with flexible arm and mobile stand. Complies with ISO 9001-2000, ISO 13485, and CE standards. Mechanical device; no software or electronic algorithm.

Indications for Use

Indicated for providing visible illumination of the surgical field or patient during minor surgical procedures.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• ST. FRANCIS OPERATING THEATRE LAMPS (K003423)

Submission Summary (Full Text)

{0}------------------------------------------------

K100234

January 5, 2010

FOOD AND DRUG ADMINISTRATION CENTER FOR DEVICES Center for Devices and Radiological Health Document Control Center (HFZ-404) 9200 Corporate Boulevard Rockville, MD 20850

FDA CDRH DMC

JAN 26 2010

JUL - 8 2010

Received

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is

- Submitter Identification. 1.
- - - - - - - -

Maria T. Guma Regulatory Affairs HILLUSA CORPORATION 7215 N.W. 46th Street Miami. Florida 33166

K24

- 2. Name of the Device:
Common Name: HM-LAMP II Serie (Hill-Med) Classification Name: Lamp, Surgical Class: ============================================================================================================================================================================== Classification number: FTD, Requlation # 878.4580

- 3. Predicate Device Information:
ST. FRANCIS OPERATING THEATRE LAMPS, K003423. ST. FRANCIS MEDICAL EQUIPMENT CO., LTD. P.O. BOX 129, SHIEN CHUANG 24299. TAIPEI SHIEN, TAIWAN, R.O.C.

- Device Description: 4.
The HM-LAMP II Series are operating lamps with high performance. Flexible movement arm and mobile stand. Designed for minor surgical procedures as well as additional operating room needs.

- 5. Intended Use:
A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

{1}------------------------------------------------

- 6. Comparison to Predicated Device:
The HM-LAMP II SERIES are used in exactly same manner as ST. FRANCIS OPERATING THEATRE LAMPS, both lamps series are intended for use as an excellent visible illumination of the surgical field or the patient.

The mainly differences between HM-LAMP II SERIES and ST. FRANCIS OPERATING THEATRE LAMPS are Weight and Dimension only.

- 7. Performance Standards
ﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

The device complies with: The design, manufacturing and quality control of the device comply with: ISO 9001-2000, CE and ISO 13485. Attach all these certificated.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three wing segments, representing the department's commitment to health, human services, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Hillusa Corporation % Ms. Maria T. Guma Regulatory Affairs 7215 N.W. 46th Street Miami, Florida 33166

Re: K100234

Trade/Device Name: HM-LAMP II Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: Class II Product Code: FTD Dated: January 05, 2010 Received: April 14, 2010

Dear Ms. Guma:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

JUL-8 2010

{3}------------------------------------------------

Page 2 - Ms. Maria T. Guma

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

P-of

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known) : K100234

Device Name: HM-LAMP II

Indications for Use:

HM-LAMP II is a device intended to be used to provide visible illumination of the surgical/field or the patient. They are designed for minor surgical procedures.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart.C)

O NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER P

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number. K100234