FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM

K050575 · Futumeds Sdn Bhd · MDM · Aug 15, 2005 · General, Plastic Surgery

Device Facts

• Record ID: K050575
• Device Name: FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
• Applicant: Futumeds Sdn Bhd
• Product Code: MDM · General, Plastic Surgery
• Decision Date: Aug 15, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1

Intended Use

The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.

Device Story

The Futumeds Safety Lancet with PALS System is a manual surgical instrument designed for capillary blood sampling. It functions by piercing the epidermal layer of the skin to obtain a small volume of blood. The device is intended for over-the-counter use by patients or healthcare providers. It operates as a single-use, disposable safety lancet. The PALS system likely refers to a protective mechanism to prevent accidental needlesticks. The device provides a simple, controlled method for blood collection, facilitating diagnostic testing or glucose monitoring by the user.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual surgical instrument; single-use safety lancet; includes PALS (protective) system; non-powered; disposable.

Indications for Use

Indicated for piercing the epidermal layer of human skin to collect small blood samples. Suitable for over-the-counter use.

Regulatory Classification

Identification

A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is enclosed in a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES · USA" is written around the top half of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 5 2005

Mr. Leong Pei Ping OA Manager Futumeds Sdn. Bhd. No: 3, Jalan Puchong, Batu 12 ½ 47100 Puchong Selangor Darul Ehsan Malaysia

Re: K050575

KU50575
Trade/Device Name: FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: MDM Dated: July 5, 2005 Received: July 7, 2005

Dear Mr. Pei Ping:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications felerenced above and nave actorially marketed predicate devices marketed in interstate for use stated in the encrosule) to regarly maximent date of the Medical Device American be any a commence phor to May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices that have been recuire in acce approval of a premarket approval application (PMA). and Cosmetic 71ct (71ct) that de never and controls provisions provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of restice, 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 If your device is classified (600 a00 m)rols. Existing major regulations affecting your device can may be subject to such address, soulations, Title 21, Parts 800 to 898. In addition, FDA may be round inter announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease be advised that I Drivesan that your device complies with other requirements of the Act that I DA has made a and regulations administered by other Federal agencies. You must or uny I with all the Act's requirements, including, but not limited to: registration and listing (21 compy with an the Fet 810 careers (01); good manufacturing practice requirements as set CI K ratt 6077, labornig (2) CFR Part 820); and if applicable, the electronic form in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2- Mr. Leong Pei Ping

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin maneting your antial equivalence of your device to a legally premarket nothication. The PDA miding of backed 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 If you desire specific advice for your do november on 5. Also, please note the regulation entitled, programs of contact the Office of Complanes at (216) =16 % art 807.97). You may obtain Misolanding by reference to prenessonsibilities under the Act from the Division of Small other general information on your response is its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## SECTION D -- INDICATIONS FOR USE

## FUTUMEDS SDN BHD

_. . Indications for Use

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510(k) Number (if known): K050575

Device Name: FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM

Indications for Use:

The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buechner for Mellersor

(Division Sign-Off Division of General, Restorative, and Neurological Devices

**510(k) Number** K050575 D-1

FUTUMEDS SDN B! (Co. No. 233125-K)