The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.

Device Description

The PLANCET blood lancet is a needle device to be loaded in a spring operated lancing device for pricking a patient's finger or palm to draw a micro-litre sample of whole blood to perform in-vitro diagnostic (IVD) blood tests. The PLANCET has a needle that is encapsulated by a plastic material that forms a body and a cap. This plastic encapsulation ensures the needle's integrity and sterility till point of use. The needle is made of a high performance and bio-compatible plastic material. The procedure to use PLANCET is to pull off the cap and to load PLANCET into a spring operated lancing device. Once triggered, the PLANCET will be actuated and retracted rapidly to penetrate the skin and create a small wound for getting some capillary whole blood.

AI/ML Overview

Here's an analysis of the PLANCET Blood Lancet's acceptance criteria and studies, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes performance deemed "comparable" to the predicate device.

Acceptance Criteria (Inferred from study goals)	Reported Device Performance (PLANCET Blood Lancet)
Durability and Strength (Needle Integrity)	Able to penetrate a 0.4mm-thick polyurethane (PU) film repeatedly (4 times) without damage to the needle tip or body. This "rules out the possibility that they will break and remain in the skin."
Pain Level during Use	Pain level for carrying out a glucose test is comparable to the predicate device.
Blood Volume obtained	Sufficient blood for carrying out a glucose test, comparable to the predicate device.
Intactness after Use	All PLANCET blood lancets inspected under magnification after actual use remained intact.

2. Sample Sizes and Data Provenance

Test Set (Focus Group Survey):
- Sample Size: 18 people.
- Data Provenance: Not explicitly stated, but it was a "focus group" and "blind study" involving actual use, implying prospective data collection in a controlled environment. The country of origin is not specified, but the manufacturer is based in Singapore, suggesting it might be local data.
Test Set (Bench Tests):
- Sample Size: Not explicitly stated for the "series of penetration tests." It mentions "PLANCET blood lancets" in plural, implying multiple devices were tested, but no specific number is given.
- Data Provenance: Retrospective (bench testing/laboratory evaluation). Country of origin is not specified.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Focus Group Survey: No experts were directly used to establish ground truth in the traditional sense for pain level or blood volume. The participants themselves reported pain levels, and "sufficient blood" was likely determined by whether a glucose test could be successfully performed.
Bench Tests: No experts were explicitly mentioned for the bench tests. The assessment of needle damage was likely based on objective inspection (e.g., under magnification).

4. Adjudication Method for the Test Set

Focus Group Survey: Not applicable in the context of expert adjudication. The study was a "blind study" comparing the new device to a predicate device, with participants reporting on their experience.
Bench Tests: No adjudication method described; assessment was objective inspection.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned. The focus group study involved human users comparing the device to a predicate, not human readers interpreting data with and without AI assistance. This device is a physical medical instrument (a lancet), not an AI-driven image analysis or diagnostic tool. Therefore, the concept of "how much human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

Not applicable. The PLANCET Blood Lancet is a physical device, not an algorithm.

7. Type of Ground Truth Used

Focus Group Survey:
- Pain Level: Subjective self-reporting by participants.
- Blood Volume: Functional assessment – whether sufficient blood was obtained for a glucose test (implied clinical utility).
- Needle Intactness: Visual inspection under magnification.
Bench Tests: Objective physical assessment of needle integrity and penetration capability.

8. Sample Size for the Training Set

Not applicable. This device is a physical lancet, not an AI/ML algorithm that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a physical device like this.

Summary

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K113513

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5. 510 (k) Summary

JUL 1 3 2012

Owner's Name:	Micropoint Technologies Pte Ltd
Address:	11, Kallang Place, #06-10/12 Singapore 339155
Telephone Number:	+65 6777 0573
Facsimile Number:	+65 6777 0573
Name of Contact Person:	Mr Chee Yen Lim
Date:	31 August 2011
Trade/Proprietary Name:	PLANCET
Common Name:	Blood Lancet
Class:	Class I (Exempt)
Classification Name:	Lancet, Blood (Product Code: FMK, Regulation No. 878.4800)
Legally MarketedPredicate Device	CLEANLET, CLEANLET XL & KIDS (K931827 )
Description of theDevice:	The PLANCET blood lancet is a needle device to be loaded in alancing device for pricking a patient's finger or palm to draw amicro-litre sample of whole blood to perform in-vitro diagnostic(IVD) blood tests. Most point-of-care (POC) IVD devices rely onmicro-sample quantities of capillary whole blood to carry out theanalysis on the blood content, which may include glucoseconcentration, cholesterol level, and the absence or presence ofantigens and antibodies. Blood lancets are commonly used by endusers who regularly perform the IVD tests at home, such aglucose monitoring tests.The predicate device normally has a stainless steel needle encapsulated by a plastic material to form a body and a cap. This encapsulation ensures the needle integrity and sterility till point of use. To use the device, the user will twist off the cap to expose the needle and load the device into a spring operated lancing device. The device will be actuated and retracted rapidly to penetrate the skin and create a small wound on the skin for getting some capillary whole blood. More volume of blood can be obtained by compressing or massaging (milking) the lanced site. On the other hand, the PLANCET has exactly the same design, i.e. a needle that is encapsulated by a plastic material that forms a body and a cap. This plastic encapsulation ensures the needle's
	integrity and sterility till point of use. However, in this case, theneedle is also made of a plastic material. The procedure to usePLANCET is to pull off the cap and to load PLANCET into aspring operated lancing device. Once triggered, the PLANCETwill be actuated and retracted rapidly to penetrate the skin andcreate a small wound for getting some capillary whole blood.
Indications for Use/Intended Use:	The PLANCET blood lancet is a puncture device to obtain micro-litre capillary whole blood samples from finger tips or palm oralternate body sites. The PLANCET blood lancet is normallyloaded in a spring-operated lancing device for rapid puncture ofskin.
TechnologicalCharacteristics of theDevice	Manufacturing aspects:The manufacturing process of the predicate device comprisesstainless steel needle fabrication and plastic over-moulding.Stainless steel wires are cut into small lengths and ground sharp,after which they are de-burred and polished by an electro-chemical process. Optionally, the ground needles can be coatedwith a layer of silicone lubricant. Finally, the ground needles arefed into an injection moulding machine to over-mould plasticmaterials e.g. polyethylene (PE) forming a body and a cap,encapsulating the ground needles. Terminal sterilization processis performed to ensure sterility of entire products. Note that thehigh temperature of the moulding process may sterilize theneedles and keep the sterile condition intact until the cap istwisted off.The manufacturing of PLANCET comprises injection mouldingof plastic needles and plastic over-moulding using polyethylenePE (exactly the same process as involved in the predicate device).Instead of cutting wire into small lengths, grinding and polishingneedles, one single injection moulding process is used tofabricate the plastic needles. The plastic material is a highperformance and bio-compatible plastic material.
	Design & Functionality aspects:The predicate device comprises a stainless steel needleencapsulated with a plastic body and a cap, the cap is twisted offto expose the needle for use. The predicate device is normallyloaded into a spring-operated lancing device, which rapidlypenetrates the skin to obtain micro-litre sample of capillary wholeblood.
	The PLANCET has exactly the same design and functionality ascompared with the predicate device. One minute difference willbe instead of twisting off the cap to expose the needle, the
PLANCET requires the end user to pull off the cap, which is asimpler procedure.
Materials aspects:The predicate device has a needle that is made of stainless steeland a body and a cap that are made of plastic materials such aspolyethylene (PE). The stainless steel material is bio-compatibleand has Elastic Modulus of roughly 200 GPa.
The PLANCET has a needle that is made of high performanceand bio-compatible plastic material and a body and a cap that aremade of plastic materials such as polyethylene (PE). The highperformance and bio-compatible plastic material has ElasticModulus of roughly 3.5 GPa. These needles have sufficientstrength for the use of pricking fingers and palms.
Non-ClinicalPerformance Data
Bench tests:The durability and strength of the plastic needles were tested in aseries of penetration tests using the PLANCET blood lancetsloaded in a spring-operated lancing device and a 0.4mm-thickpolyurethane (PU) film. Our data show that the PLANCET bloodlancets are able to penetrate the PU film repeatedly withoutdamage to the needle tip or body.
Focus group survey:To test the performance (pain level and blood volume) of thePLANCET blood lancets in actual use, a focus group of 18 peoplewas established to conduct a blind study involving a predicatedevice and the PLANCET. The results showed that the pain leveland the blood volume for carrying out a glucose test arecomparable to the predicate device. All PLANCET blood lancetswere inspected under magnification, and all PLANCET bloodlancets remained intact.
Our study shows that the PLANCET blood lancets when usedwith a spring-operated lancing device have comparablefunctionality performance compared to the predicate device. Inparticular, the PLANCET blood lancets can penetrate repeatedly(4 times) a thick and hard PU film without damage, ruling out thepossibility that they will break and remain in the skin. Our studyalso shows that PLANCET blood lancets when used with aspring-operated lancing device can obtain sufficient blood forcarrying out a glucose test.
Conclusions
Drawing conclusions from our non-clinical data, the PLANCETblood lancets are substantially similar to the predicate device interms of performance and are safe and effective for the intended

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K 11 35 13

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and three wave-like lines below it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle.

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

Micropoint Technologies PTE, Limited % Mr. Chee Yen Lim 11. Kallang Place #06-10/12 Singapore, Singapore 339155

JUL 13 2012

Re: K113513

Trade/Device Name: PLANCET Blood Lancet Regulation Number: 21 CFR 878.4800 Regulation Name: Manual surgical instrument for general use Regulatory Class: I Product Code: FMK Dated: June 14, 2012 Received: June 18, 2012

Dear Mr. Lim:

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

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Page 2 - Mr. Chee Yen Lim

CFR Part 807): labeling (21 CFR Part 801); medical device 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm

Sincerely yours,

Mark N. Melkerson Director

Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

0(k) Number (if known): K113513

Device Name: PLANCET Blood Lancet

Indications for Use:

The PLANCET blood lancet is a puncture device to obtain micro-litte capillary whole blood samples from finger tips or palm or alternate body sites. The PLANCET blood lancet is normally loaded in a spring-operated lancing device for rapid puncture of skin.

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)

Nilk Doyle for mxm

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

510(k) Number K. 113513

Regulation Number and Section

§ 878.4850 Blood lancets.

(a)
Single use only blood lancet with an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base (including an integral sharps injury prevention feature) that is used to puncture the skin to obtain a drop of blood for diagnostic purposes. The integral sharps injury prevention feature allows the device to be used once and then renders it inoperable and incapable of further use.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and must include a sharps injury prevention feature.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use and that the integral sharps injury prevention feature will irreversibly disable the device after one use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device and its sharps injury prevention feature.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(b)
Single use only blood lancet without an integral sharps injury prevention feature —(1)Identification. A disposable blood lancet intended for a single use that is comprised of a single use blade attached to a solid, non-reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that the structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) Handwashing instructions for the user before and after use of the device.
(C) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(D) Instructions for the safe disposal of the device.
(E) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vi) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Discard the entire device after use.”
(B) “Warning: Not intended for more than one use. Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested.”
(c)
Multiple use blood lancet for single patient use only —(1)Identification. A multiple use capable blood lancet intended for use on a single patient that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class II (special controls). The special controls are:(i) The design characteristics of the device must ensure that:
(A) The lancet blade can be changed with every use, either manually or by triggering a blade storage unit to discard the used blade and reload an unused blade into the reusable base; and
(B) The structure and material composition are consistent with the intended use and address the risk of sharp object injuries and bloodborne pathogen transmissions and allow for validated cleaning and disinfection.
(ii) Mechanical performance testing must demonstrate that the device will withstand forces encountered during use.
(iii) The device must be demonstrated to be biocompatible.
(iv) Sterility testing must demonstrate the sterility of any device component that breaches the skin (
e.g., blade).(v) Validation testing must demonstrate that the cleaning and disinfection instructions are adequate to ensure that the reusable lancet base can be cleaned and low level disinfected.
(vi) Labeling must include:
(A) Detailed descriptions, with illustrations, of the proper use of the device.
(B) The Environmental Protection Agency (EPA) registered disinfectant's contact time for disinfectant use.
(C) Handwashing instructions for the user before and after use of the device.
(D) Instructions on preparation (
e.g., cleaning, disinfection) of the skin to be pierced.(E) Instructions on the cleaning and disinfection of the device.
(F) Instructions for the safe disposal of the device.
(G) Instructions for use must address the safe storage of the reusable blood lancet base between uses to minimize contamination or damage and the safe storage and disposal of the refill lancet blades.
(H) Labeling must be appropriate for the intended use environment.
(
1 ) For those devices intended for health care settings, labeling must address the health care facility use of these devices, including how these lancets are to be used with personal protective equipment, such as gloves.(
2 ) For those devices intended for use in the home, labeling must be written so that it is understandable to lay users.(vii) Labeling must also include the following statements, prominently placed:
(A) “For use only on a single patient. Disinfect reusable components according to manufacturer's instructions between each use.”
(B) “Used lancet blades must be safely discarded after a single use.”
(C) “Warning: Do not use on more than one patient. Improper use of blood lancets can increase the risk of inadvertent transmission of bloodborne pathogens, particularly in settings where multiple patients are tested. The cleaning and disinfection instructions for this device are intended only to reduce the risk of local use site infection; they cannot render this device safe for use for more than one patient.”
(d)
Multiple use blood lancet for multiple patient use —(1)Identification. A multiple use capable blood lancet intended for use on multiple patients that is comprised of a single use blade attached to a solid, reusable base that is used to puncture the skin to obtain a drop of blood for diagnostic purposes.(2)
Classification. Class III (premarket approval).(3)
Date PMA or notice of completion of a PDP is required: A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before May 22, 2024, for any multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before May 22, 2024, been found to be substantially equivalent to a multiple use blood lancet for multiple patient use described in paragraph (d)(1) of this section that was in commercial distribution before May 28, 1976. Any other multiple use blood lancet for multiple patient use shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.