(161 days)
The device is intended to pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.
Not Found
This looks like a 510(k) clearance letter for a medical device (FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM). However, the provided document does not contain the kind of detailed study information (acceptance criteria, reported performance, sample sizes, ground truth methodology, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive summary of safety and effectiveness data.
The FDA 510(k) clearance process primarily evaluates substantial equivalence to a predicate device, rather than requiring extensive clinical trials for all devices, especially Class I devices like this one (manual surgical instrument for general use).
Therefore, based only on the provided text, I cannot extract the detailed information requested in your prompt. The document primarily states:
- Device Name: FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM
- Regulation Number/Name: 21 CFR 878.4800, Manual surgical instrument for general use (Class I)
- Intended Use/Indications for Use: To pierce the epidermal layer of the human skin for the collection of a small volume of blood sample.
- Clearance: FDA finding of "substantial equivalence" to legally marketed predicate devices.
What is missing from the document to answer your questions:
- No specific acceptance criteria for device performance are mentioned. For a Class I device like a lancet, acceptance usually revolves around safe design, manufacturing quality, and meeting basic functional requirements (e.g., proper puncture, sterility, ease of use). These wouldn't typically be expressed as statistical performance metrics like sensitivity/specificity for a diagnostic AI.
- No study details: There is no mention of a formal clinical study, sample sizes, data provenance, ground truth establishment, expert adjudication, MRMC studies, or standalone algorithm performance. This type of detail is generally not included in the 510(k) clearance letter itself.
- No AI component: The device is a "SAFETY LANCET." There is no indication that it includes any artificial intelligence (AI) component, which is a prerequisite for many of your questions (e.g., "human readers improve with AI," "standalone algorithm performance").
Conclusion based on provided text:
I cannot fulfill your request as the provided FDA clearance letter for the FUTUMEDS™ SAFETY LANCET WITH PALS SYSTEM does not contain information about acceptance criteria, study details, or AI performance metrics. This type of information would be found in the manufacturer's more detailed 510(k) submission summary or a separate clinical study report, neither of which is present here.
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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 (800) 638-2041 or (301) 443-6597 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
$\frac{1}{2} + \frac{1}{2} = 1$
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)
§ 878.4800 Manual surgical instrument for general use.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.