(82 days)
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.
The provided text is a 510(k) summary for the LDE4 Lancing Device. It details the device's technical characteristics and the performance data submitted to support its substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance in distinct metrics like sensitivity, specificity, accuracy, or F1 score, which are common for AI/ML-based diagnostic devices. This document focuses on demonstrating that the lancing device performs its intended mechanical function, is biocompatible, and can be properly cleaned and disinfected.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific numerical acceptance criteria in the format of a typical diagnostic device performance table (e.g., sensitivity, specificity). Instead, the performance evaluations verify that the device functions as intended and meets safety standards. The "acceptance criteria" are implied by the successful completion and positive results of the various tests.
| Performance Characteristic | Acceptance Criteria (Implied by successful test) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards for medical devices | Cytotoxicity testing: Passed Skin sensitization: Passed Intracutaneous reactivity: Passed |
| Cleaning and Disinfection | Complete inactivation of HBV and no performance/physical change after 520 cycles | Virus elimination efficacy tests performed: Demonstrated complete inactivation of Hepatitis B Virus (HBV) on ABS and POM. Robustness test: No change in performance or physical appearance of surface materials after 260 cleaning and 260 disinfection cycles (520 total), simulating 5 years of single-patient use. |
| Puncture Depth | (Various levels with ±0.3mm tolerance) | 1: 0.5 ± 0.3mm 1.5: 0.7 ± 0.3mm 2: 0.9 ± 0.3mm 2.5: 1.1 ± 0.3mm 3: 1.3 ± 0.3mm 3.5: 1.5 ± 0.3mm 4: 1.7 ± 0.3mm 4.5: 1.9 ± 0.3mm 5: 2.1 ± 0.3mm |
| Mechanical Performance | Functional performance as described | Appearance: Verified Basic dimensions: Verified Compatible performance: Verified Bounce performance: Verified Puncture Test: Verified Adjustable performance: Verified Lancet unloading performance: Verified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for each particular test type. For instance, the number of devices or material samples used for biocompatibility or cleaning/disinfection validation is not specified. The studies appear to be prospective bench tests and laboratory evaluations, not clinical trials with human subjects as a "test set" in the context of diagnostic AI. The provenance is implied to be laboratory testing conducted by the manufacturer or its contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable to the provided document. The LDE4 Lancing Device is a mechanical device, and its performance evaluation does not involve establishing ground truth through expert consensus as would be typical for image-based diagnostic AI. The "ground truth" here is objective physical measurements and established biological/chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretation, which is not relevant for the type of bench testing described for a lancing device.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The LDE4 Lancing Device is a standalone mechanical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LDE4 Lancing Device is a mechanical lancing device, not an algorithm, and therefore does not have "standalone" AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance described in this document is based on:
- Established physical and chemical standards: For puncture depth measurements, material properties, and mechanical functionality.
- Standardized biological testing methods: For biocompatibility (ISO 10993-1) and virus inactivation efficacy.
8. The sample size for the training set
This information is not applicable. The LDE4 Lancing Device is a mechanical device and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a mechanical lancing device.
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11/23/2022
i-SENS, Inc. H.S. Yoo Regulatory Affairs Assistant Manager 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, Seoul 06646 Korea. South
Re: K222656
Trade/Device Name: LDE4 Lancing Device Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: QRL Dated: September 27, 2022 Received: September 28, 2022
Dear H.S. Yoo:
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) K222656
Device Name LDE4 Lancing device
Indications for Use (Describe)
LDE4 lancing device is used with a disposable blood lancet 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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510(k) Summary
Prepared in accordance with the requirements of 21 CFR 807.92
1. Applicant Information
| Name | : i-SENS, Inc. |
|---|---|
| Address | : 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, Korea 06646 |
| Applicant Contact | : H.S. Yoo / Regulatory Affairs Specialist |
| Correspondent | : i-SENS, Inc., 43, Banpo-Daero 28-Gil, Seocho-Gu, Seoul, Korea 06646 |
| : hsyoo@i-sens.com | |
| Telephone number | : +82-2-910-0516 |
| Prepared Date | : September 27, 2022 |
2. Manufacturer Information
| Name | : SteriLance Medical (Suzhou) Inc. | ||||
|---|---|---|---|---|---|
| Address | : No.168 PuTuoShan Road, New District, 215153 Suzhou,Jiangsu, P. R. China | ||||
| Contact Person | : Susan Sun / Quality Manager | ||||
| : registration@sterilance.com |
3. Medical Device Information
| Device Name | : LDE4 Lancing Device |
|---|---|
| Common name | : Lancing device, Blood lancet |
| Regulation Number | : 21CFR 878.4850, Multiple use blood lancet for single patient use only |
| Class | : Class II |
| Product Code | : QRL |
| Submission Type | : Special 510(k) |
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4. Predicate Device Information
ACON Laboratories, Inc., On call® Lancing device under K113332
5. Device Description
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.
6. Intended Use, Indications for Use
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
| Candidate device:LDE4 Lancing Device | Predicate Device:On Call® Lancing device | Comparison | |
|---|---|---|---|
| Product code | QRL | FMK, NBW | Different 1 |
| Regulationnumber | 878.4850 | 878.4850, 862.1345 | Different 1 |
| Classification | Class II | Same | |
| Intended use&Indicationsfor use | LDE4 Lancing device isused with a disposableblood lancet to obtain acapillary blood samplefrom the fingertip fortesting utilizing smallamounts of blood. | On Call® Lancing Deviceis used with On Call®disposable sterile lancetsto draw capillary bloodfrom the fingertip, palm(at the base of the thumb)or forearm, for bloodglucose testing or othertesting utilizing small | Same |
7. Technological characteristics compared to the predicate device
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| amounts of blood. The On | ||||||
|---|---|---|---|---|---|---|
| call ® Lancing Device is | ||||||
| intended to be used by a | ||||||
| single patient and should | ||||||
| not be shared. | ||||||
| Shelf life | 5 years | Same | ||||
| Depth | 9 levels by twisting cap | 6 levels by twisting cap | Same | |||
| adjustment | ||||||
| Penetration | Depth (mm) | Penetration | Depth | The deepest | ||
| level | level | (mm) | penetration | |||
| 1 | $0.5 ± 0.3$ | 1 | $0.6 ± 0.3$ | depth is the | ||
| 1.5 | $0.7 ± 0.3$ | 2 | $0.9 ± 0.3$ | same | ||
| 2 | $0.9 ± 0.3$ | 3 | $1.2 ± 0.3$ | |||
| 2.5 | $1.1 ± 0.3$ | 4 | $1.5 ± 0.3$ | |||
| 3 | $1.3 ± 0.3$ | 5 | $1.8 ± 0.3$ | |||
| 3.5 | $1.5 ± 0.3$ | 6 | $2.1 ± 0.3$ | |||
| 4 | $1.7 ± 0.3$ | |||||
| 4.5 | $1.9 ± 0.3$ | |||||
| 5 | $2.1 ± 0.3$ | |||||
| Mechanical | Spring-driven | Same | ||||
| loading | ||||||
| Puncture sites | Fingertip | FingertipPalmForearm | Different 2 | |||
| Materials of | Priming barrel: ABSEjector: POMLancet holder: ABSTrigger button: ABSAdjusting head inner core:ABSOut cover: ABSEnd Cap: ABS | Plastic composition: ABSClear cap: TransparentABS | Different 3 | |||
| parts in | ||||||
| contact with | ||||||
| human body | ||||||
| Disinfectantused for | Clorox Healthcare BleachGermicidal Wipes (EPA.67619-12) | DisCide UltraDisinfecting Wipes (EPA.10492-4) | Different 4 | |||
| cleaning |
Different 1: According to the FDA final order to reclassify blood lancets.
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Different 2: Only to obtain capillary blood samples from the fingertip. Different 3: Includes a POM part, which is a known biocompatible material that have been validated for biocompatibility, cleaning and disinfection.
Different 4: Disinfectant validated in the cleaning and disinfection validation.
8. Performance Data
The following performance data were provided in support of the substantial equivalence determination
8.1 Biocompatibility Testing
The biocompatibility evaluation for the proposed device was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity testing
- Skin sensitization
- Intracutaneous reactivity
8.2 Cleaning and Disinfection Validation
Virus elimination efficacy tests were performed on the surface materials of the LDE4 lancing device (ABS and POM), and a robustness test was performed on the LDE4 lancing device using Clorox Healthcare Bleach Germicidal Wipes; EPA registration # 67619-12 (Active ingredient: Sodium hypochlorite (0.55%)).
The validation results demonstrated complete inactivation of Hepatitis B Virus (HBV) on the surface materials of the lancing device. Robustness test results also demonstrated that there was no change in performance or physical appearance in the surface materials of the lancing device after 260 cleaning and 260 disinfection cycles (520 in total) designed to simulate cleaning and disinfection to support 5 years of single-patient use.
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8.3 Non-clinical data
The bench testing performed verifies that the performance of the subject devices are substantially equivalent in terms of critical performance characteristics to the predicate device. These tests include:
- Appearance
- Basic dimensions
- Compatible performance
- Bounce performance
- Puncture Test
- Adjustable performance ●
- Lancet unloading performance
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the candidate device is substantially equivalent to the predicate device.
§ 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.