(85 days)
Not Found
No
The device description and operating principle are purely mechanical and do not mention any computational or data-driven components indicative of AI/ML.
No.
The device is used to obtain a blood sample, which is a diagnostic purpose, not a therapeutic one. It does not treat or cure any condition.
No
The device is designed to obtain capillary blood samples for testing, not to perform the diagnostic testing itself. It is a tool for sample collection.
No
The device description clearly outlines physical components like needles, springs, protective caps, and a lancing device (SafeLan®-Pro) with a loading handle and operation button. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the SafeLan® and SafeLan®-Pro devices are not IVDs (In Vitro Diagnostics).
Here's why:
- Intended Use: The intended use is explicitly stated as "performing skin punctures on patients for the purpose of obtaining capillary blood samples." This describes a device used to collect a sample, not a device used to test or analyze a sample.
- Device Description: The description focuses on the mechanical components and operation of the lancing device and lancet, which are used for the physical act of obtaining blood. There is no mention of reagents, test strips, or any components that would be used to perform a diagnostic test on the collected blood.
- Lack of Diagnostic Function: The devices facilitate the collection of blood, which can then be used for diagnostic testing (often with an IVD device like a blood glucose meter), but they themselves do not perform any diagnostic function.
In summary, SafeLan® and SafeLan®-Pro are devices used for sample collection, which is a step that often precedes in vitro diagnostic testing, but they are not IVD devices themselves.
N/A
Intended Use / Indications for Use
SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples.
SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.
Product codes
QRK
Device Description
SafeLan® blood lancet is a small medical device used for capillary blood sampling. The SafeLan® is a blood lancet consisting of protective cap, needle protector, spring, lancet, and needle. The main component of blood lancet is the small, sharp objects that are used to prick the skin to obtain a small quantity of blood for testing. SafeLan® has 2 models depending on the diameter of the needle.
- SafeLan® 26G: 0.46 +/- 0.05mm
- SafeLan® 30G: 0.30 +/- 0.05mm
Lancing device (SafeLan®-Pro) combines with the SafeLan® to operate the needle to prick the skin.
SafeLan®-Pro is used with SafeLan® to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. SafeLan® is used with compatible lancing device (SafeLan®-Pro) for capillary blood sampling.
Safel an 9-Pro consists of loading handle, operation button, depth adjustment confirmation part.
The operating principle of SafeLan®-Pro is driven by force of the simple operating sequence is as follows.
-
Insert the SafeLan® clockwise to the front thread of the SafeLan®-Pro.
-
Pull the needle protector of SafeLan® to remove it.
-
Pull and release the loading handle of SafeLan®-Pro.
-
Press the operation button of SafeLan®-Pro.
-
Remove the used SafeLan® from the SafeLan®-Pro by turning them counterclockwise.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip
Indicated Patient Age Range
child older than 8 years and adults
Intended User / Care Setting
single patient use by lay users in a home or general environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The mechanical performance test was performed to verify the percussion of lancets for each puncture depth. The firmness force test was also performed in the accelerated aging test of proposed device. According to the test result, puncture depths and exposed device and met its specifications, and the firmness force was within acceptance criteria in the accelerated aging test.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Applicable
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 13, 2023
Bosungmeditech Co., Ltd. % Andrew Chun President Andrew Chun 6300 Old York Rd. Apt. 914, Philip Murray House Philadelphia, Pennsylvania 19141
Re: K230759
Trade/Device Name: SafeLan® (2 models/SafeLan 26G, SafeLan 30G), SafeLan®-Pro (1 model/SafeLan®-Pro) Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRK Dated: March 2, 2023 Received: March 20, 2023
Dear Andrew Chun:
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.
1
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 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 (QS) 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 medical devices and radiation-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
| Digitally signed by | |||
|---|---|---|---|
| Mark | Mark Trumbore -S | ||
| Trumbore -S Date: 2023.06.13 13 -04'00' | |||
Mark Trumbore, 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K230759
Device Name SafeLan®, SafeLan®-Pro
Indications for Use (Describe)
SafeLan® is sterile, single use device that has been designed for single patient use by lay users in a home. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples.
SafeLan®-Pro: Use with SafeLan® for capillary blood sampling and the SafeLan®-Pro as the multiple use execution device which the SafeLan® lancet attaches.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
| 510(k) Summary | Prepared on: 2023-06-06 | |
|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | |
| Applicant Name | BOSUNGMEDITECH CO., LTD. | |
| Applicant Address | #F, 107 Donghwagongdan-ro, Munmak-eup Wonju Korea, South | |
| Applicant Contact Telephone | 82-10-8790-4789 | |
| Applicant Contact | Mr. Yang Ho Song | |
| Applicant Contact Email | bosungmt@naver.com | |
| Correspondent Name | Andrew Chun | |
| Correspondent Address | 6300 OLD YORK RD. APT. 914 , PHILIP MURRAY HOUSE | |
| PHILADELPHIA PA 19141 United States | ||
| Correspondent Contact Telephone | 215-2687249 | |
| Correspondent Contact | Mr. Andrew Chun | |
| Correspondent Contact Email | jcs268268@gmail.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | SafeLan® (2 models/SafeLan 26G, SafeLan 30G); | |
| SafeLan®-Pro (1 model/SafeLan®-Pro) | ||
| Common Name | Blood lancets | |
| Classification Name | Single Use Only Blood Lancet Without An Integral Sharps Injury | |
| Prevention Feature | ||
| Regulation Number | 878.4850 | |
| Product Code | QRK | |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
Legally Marketed Predicate Devices
Device Description Summary
Predicate #
21 CFR 807.92(a)(3)
Predicate Trade Name (Primary Predicate is listed first) Accu-Check Softclix Blood Lancing System K214022 QRK
Product Code
21 CFR 807.92(a)(4)
- SafeLan®
SafeLan® blood lancet is a small medical device used for capillary blood sampling. The SafeLan® is a blood lancet consisting of protective cap, needle protector, spring, lancet, and needle. The main component of blood lancet is the small, sharp objects that are used to prick the skin to obtain a small quantity of blood for testing. SafeLan® has 2 models depending on the diameter of the needle.
- SafeLan® 26G: 0.46±0.05mm - SafeLan® 30G: 0.30±0.05mm
4
Lancing device (SafeLan®-Pro) combines with the SafeLan® to operate the needle to prick the skin.
2. SafeLan®-Pro
SafeLan®-Pro is used with SafeLan® to draw capillary blood from the fingertip, for testing utilizing small amounts of blood. SafeLan® is used with compatible lancing device (SafeLan®-Pro) for capillary blood sampling.
Safel an 9-Pro consists of loading handle, operation button, depth adjustment confirmation part.
The operating principle of SafeLan®-Pro is driven by force of the simple operating sequence is as follows.
-
Insert the SafeLan® clockwise to the front thread of the SafeLan®-Pro.
-
Pull the needle protector of SafeLan® to remove it.
-
Pull and release the loading handle of SafeLan®-Pro.
-
Press the operation button of SafeLan®-Pro.
-
Remove the used SafeLan® from the SafeLan®-Pro by turning them counterclockwise.
Intended Use/Indications for Use
Safel an® is sterile, single use device that has been designed for single patient use by lay users in a home or general environment. Their intended use is for performing skin punctures on patients for the purpose of obtaining capillary blood samples.
SafeLan®-Pro: Use with SafeLan® for capillary blood sampling.
Indications for Use Comparison
The described indications for use (e.g. General and Plastic Surgery) for the proposed device is exactly the same as the predicate device.
Technological Comparison
Technological Comparison
Many aspects of the proposed device are similar to those of the predicate device, except for some minor differences:
Note 1: Anatomical sites, Intended population, Depth of penetration
Anatomical sites, intended population, and needle gauge of proposed device are different with predicate device. (*1) Krelz at al. recommended that if the recommended puncture site is finger, the recommended incision depth is up to 2.4mm for child older than 8 years and adults.
Anatomical site of proposed device is fingertip, intended population of proposed device is child older than 8 years and adults, and maximum depth of proposed device is 1.75mm.
Therefore, the maximum depth of the proposed device's needle depending on the anatomical sites and intended population is valid and this difference in the proposed device and predicate device do not raise concerns related to device safety and effectiveness.
- 1: Capillary blood sampling: national recommendations on behalf of the Croatian Society of Medical Biochemistry and Laboratory Medicine, http://dx.doi.org/10.11613/BM.2015.034
Note 2: Needle Gauge (Out Diameter)
The gauge of proposed device is different from the lancets of predicate device. In order to confirm the performance between the different lancet specifications, proposed device was verified by measuring the needle of proposed device was firmly fixed in lancet housing at each time point of accelerated aging test. The safety and effectiveness of proposed device was substantially equivalent to predicate device.
Note 3: Depth Adjustment
The proposed device has 5 levels of puncture depth, which are adjustable by rotating the selector cap. 11 levels of puncture depth, which are adjustable by rotating the rotatable cap and AST cap.
The mechanical performance test was performed to verify the percussion of lancets for each puncture depth. The firmness force test was also performed in the accelerated aging test of proposed device.
According to the test result, puncture depths and exposed device and met its specifications, and the firmness force was within acceptance criteria in the accelerated aging test. This difference does not affect the basic design principle, usage, effectiveness and safety of the proposed device, and no question is raised regarding to effectiveness and safety.
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)
5
Not Applicable