Medipoint Blood Lancets

K223480 · Medipoint Holdings, LLC · QRK · Jan 13, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K223480
• Device Name: Medipoint Blood Lancets
• Applicant: Medipoint Holdings, LLC
• Product Code: QRK · General, Plastic Surgery
• Decision Date: Jan 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4850
• Device Class: Class 2

Intended Use

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Device Story

Medipoint Blood Lancets are single-use, manual surgical instruments designed to obtain capillary blood samples from the fingertip. The device consists of a single piece of 430 stainless steel featuring a sharp, beveled tip for skin piercing and a knurled grip for manual handling. The device is used by patients or clinicians in point-of-care settings; it is operated manually by pressing the tip against the skin. After a single use, the device is discarded into a sharps container. The device provides a simple, mechanical method for blood collection, facilitating diagnostic testing by enabling access to small blood volumes.

Clinical Evidence

Bench testing only. No clinical data. Performance testing confirmed the device withstands usage forces without bending or damage. Biocompatibility testing per ISO 10993-1 included cytotoxicity, sensitization, irritation/intracutaneous reactivity, and acute systemic toxicity (material-mediated pyrogenicity), all with passing results.

Technological Characteristics

Constructed from 430 stainless steel. Single-piece, manual, non-powered design. Dimensions: 1 5/8" long, 15/64" wide, 0.007" thick. Beveled tip configuration. Sterilized via validated moist heat process. Biocompatible per ISO 10993.

Indications for Use

Indicated for obtaining capillary blood samples from the fingertip for diagnostic testing in patients requiring small blood volumes. Suitable for over-the-counter use.

Regulatory Classification

Identification

The regulation covers four types of blood lancets: (a) Single use only blood lancet with an integral sharps injury prevention feature; (b) Single use only blood lancet without an integral sharps injury prevention feature; (c) Multiple use blood lancet for single patient use only; and (d) Multiple use blood lancet for multiple patient use. All are defined as disposable or reusable devices comprised of a blade attached to a base used to puncture the skin to obtain a drop of blood for diagnostic purposes.

Special Controls

*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.

Predicate Devices

• Medipoint Blood Lancets (510(k)-Exempt prior to reclassification)
• Facet Technologies LLC Facet 28G Universal Lancet (K221433)

Submission Summary (Full Text)

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January 13, 2023

Medipoint Holdings, LLC Rochelle Stern Managing Partner 72 East 2nd St. Mineola, New York 11501

Re: K223480

Trade/Device Name: Medipoint Blood Lancets Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: November 18, 2022 Received: November 18, 2022

Dear Rochelle Stern:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

**Jessica Carr -S**

for Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

510(k) Number (if known) K223480

Device Name Medipoint Blood Lancets

Indications for Use (Describe)

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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# K223480 – 510(k) Summary

# Date Prepared:

01/13/2023

# Submitted By:

Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501

## Contact:

| Name: | Rochelle Stern |
|------------|------------------------|
| Title: | Managing Partner |
| Telephone: | 516-294-8822 |
| Email: | [e-mail] |

#### Device:

| Trade Name: | Medipoint Blood Lancets |
|----------------------|--------------------------------------------------------------------------------------|
| Common Name: | Blood Lancet |
| FDA Product Code: | QRK |
| Classification Name: | Single Use Only Blood Lancet Without An Integral Sharps Injury<br>Prevention Feature |
| 510(k) Number: | K223480 |

#### Predicate Devices:

The device is substantially equivalent to the following predicate devices:

| Primary Predicate: | Medipoint Blood Lancets (510(k)-Exempt prior to reclassification |
|----------------------|------------------------------------------------------------------|
| Secondary Predicate: | Facet Technologies LLC Facet 28G Universal Lancet (K221433) |

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## Device Description:

Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

Medipoint Blood Lancets are single-use only and are discarded into a sharps container immediately after use.

The Medipoint Blood Lancet is constructed from a single piece of stainless steel with a sharp, beveled tip for piercing the skin and a knurled grip for maintaining a secure grip on the lancet. Each Medipoint Blood Lancet is individually packaged in a paper package and sterilized in the package via a validated moist heat sterilization process.

## Indications for Use:

Th Medipoint Blood Lancets are indicated to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.

# Technological Characteristics and Performance Data (Predicate Comparison):

The device has equivalent design, intended use, material performance, and biocompatibility compared to the predicate devices.

The device has equivalent non-clinical performance as the primary predicate device.

A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below.

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#### Traditional 510(k): Medipoint Holdings, LLC 72 East 2nd Street Mineola, NY 11501 510(k) Number: K223480

# Table 1: Comparison to Predicate Devices

| Product<br>Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Substantial Equivalence |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant | Medipoint Holdings, LLC | Medipoint Holdings, LLC | Facet Technologies LLC | N/A |
| Product/Trade<br>Name | Medipoint Blood Lancets | Medipoint Blood Lancets | Facet 28G Universal<br>Lancet | N/A |
| Common Name | Blood Lancet | Blood Lancet | Blood Lancet | Same Common Name |
| Device<br>Classification<br>Name | Single Use Only Blood<br>Lancet Without An Integral<br>Sharps Injury Prevention<br>Feature | Manual surgical<br>instrument for general use | Single Use Only Blood<br>Lancet Without An Integral<br>Sharps Injury Prevention<br>Feature | Different device classification name<br>compared to primary predicate due to<br>reclassification order. However, the<br>device is identical. Same<br>classification name as secondary<br>predicate. |
| 510(k) Number | K223480 | N/A, 510(k)-exempt | K221433 | N/A |
| Classification<br>Regulation | 21 CFR 878.4850 | 21 CFR 878.4800 | 21 CFR 878.4850 | Different classification regulation<br>compared to primary predicate due to<br>reclassification order. However, the<br>device is identical. Same<br>classification regulation as secondary<br>predicate. |
| Product Code | QRK | FMK | QRK | Different product code compared to<br>primary predicate due to<br>reclassification order. However, the<br>device is identical. Same product<br>code as secondary predicate. |
| Intended Use | Medipoint Blood Lancets<br>are indicated to obtain a<br>capillary blood sample<br>from the fingertip for | Medipoint Blood Lancets<br>are intended for use to<br>puncture the skin to obtain | The Facet 28G Universal<br>Lancet is intended to<br>perform a skin puncture of<br>a finger or alternate site | The subject device is intended for the<br>same use as the primary predicate<br>device and similar intended use |
| Product<br>Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Substantial Equivalence |
| | testing utilizing small<br>amounts of blood.<br><br>Medipoint Blood Lancets<br>are single-use only. | a drop of blood for<br>diagnostic purposes.<br><br>Medipoint Blood Lancets<br>are single-use only. | (palm of the hand, upper<br>arm, or forearm) for<br>collection of a droplet of<br>capillary blood for<br>subsequent diagnostic<br>testing. The Lancet may<br>be used in combination<br>with a reusable lancet<br>base (lancing device) that<br>accepts a universal-type<br>lancet to perform a lancing<br>event. The Facet<br>28G Universal Lancet is<br>for single use only on an<br>individual patient. | compared to the secondary predicate<br>device. |
| Indications for<br>Use | Medipoint Blood Lancets<br>are indicated to obtain a<br>capillary blood sample<br>from the fingertip for<br>testing utilizing small<br>amounts of blood. | Medipoint Blood Lancets<br>are indicated for fingertip<br>blood sampling for<br>diagnostic purposes. | The Facet 28G Universal<br>Lancet is a sterile,<br>disposable single use<br>device used to obtain a<br>droplet of capillary blood<br>for<br>subsequent diagnostic<br>testing from the finger or<br>an alternative site, such as<br>the palm, upper arm, or<br>forearm. The Lancet is<br>to be properly disposed of<br>after a single use on an<br> | There are minor differences in the<br>indications for use statement between<br>the subject device the predicate<br>devices but the indications for use are<br>substantially equivalent. |
| Sterility | Sterile (Moist Heat) | Sterile (Moist Heat) | Sterile (Gamma<br>Irradiation) | Identical sterilization process and<br>parameters compared to the primary<br>predicate. While the sterilization |
| Product<br>Characteristic | Subject Device | Primary Predicate | Secondary Predicate | Substantial Equivalence |
| | | | | method is difference from the<br>secondary predicate, both are<br>provided sterile. |
| Type of Use | Over-The-Counter | Over-The-Counter | Over-The-Counter | Identical. |
| Device<br>Dimensions | 1 5/8" Long, 15/64" Wide,<br>0.007" Thick (0.025 –<br>0.032" Thick with knurls) | 1 5/8" Long, 15/64" Wide,<br>0.007" Thick (0.025 –<br>0.032" Thick with knurls) | Needle: 3.1±0.45 mm<br>Body: length not disclosed<br>in 510(k) summary | Device dimensions are identical to the<br>primary predicate. |
| Maximum<br>Penetration<br>Depth | 7/64 inch (2.78 mm) ±<br>1/64 inch (0.40 mm) | 7/64 inch (2.78 mm) ±<br>1/64 inch (0.40 mm) | 3.1±0.45 mm | Similar, the Medipoint Blood Lancet<br>maximum penetration is less than the<br>secondary predicate. |
| Materials of<br>Construction | 430 Stainless Steel | 430 Stainless Steel | 304 Stainless Steel needle<br>with low density<br>polyethylene body | Materials of construction are identical<br>to the primary predicate. The subject<br>device material and needle portion of<br>the secondary predicate are both<br>constructed of stainless steel. |
| Tip<br>Configuration | Bevel | Bevel | Bevel | Substantially equivalent, all devices<br>have a beveled point. |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Substantially equivalent, the subject<br>device has undergone<br>biocompatibility testing in accordance<br>with ISO 10993-1 based on the<br>intended nature and duration of<br>contact. |

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# Non-Clinical Testing:

Non-clinical testing performed for the Medipoint Blood Lancets includes testing performed to ensure that predetermined performance criteria and conformance to special controls (21 CFR 878.4850) were met.

# Performance Testing

The Medipoint Blood Lancets are constructed from a single piece of stainless steel and have no moving parts, joints, or caps which require mechanical testing. Performance testing completed for the Medipoint Blood Lancets demonstrates that the device withstands the forces encountered during use without bending or damage.

#### Biocompatibility Testing

Biocompatibility testing was selected based on ISO 10993 and the nature of device contact. The following biocompatibility tests were performed with passing results:

- Cytotoxicity ●
- Sensitization
- Irritation or Intracutaneous Reactivity .
- . Acute Systemic Toxicity (Material-Mediated Pyrogenicity)

All biocompatibility testing passed and demonstrates an acceptable biocompatibility profile for the intended nature and duration of contact of this device.

#### Conclusions:

The subject device and the predicate devices underwent evaluation for equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. This evaluation demonstrates that the subject device is substantially equivalent to the predicate devices.