(131 days)
Safety-Lancets with safety feature are used for single use capillary blood sampling.
The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available. The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.
The provided text describes the 510(k) submission for a Safety Lancet, and while it covers non-clinical testing, it does not include information about a study that assesses AI performance. The document focuses on the substantial equivalence of the new Safety Lancet to a predicate device, primarily through bench tests verifying physical and functional aspects.
Therefore, I cannot extract the detailed information requested regarding AI acceptance criteria and study performance from this document. The questions about AI performance, test set characteristics, expert ground truth establishment, MRMC studies, standalone performance, and training set details are not applicable to this Safety Lancet submission.
The document describes non-clinical testing for a medical device (a lancet), not a software or AI-driven diagnostic tool.
However, I can provide the acceptance criteria and reported device performance from the provided text as it relates to the physical device:
1. A table of acceptance criteria and the reported device performance (for the physical device):
| Acceptance Criteria (Design Specification Tests) | Reported Device Performance (Conclusion) |
|---|---|
| Aesthetics and correct assembly | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in all design specifications, including aesthetics and correct assembly.) |
| Inspection for self-activation | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in preventing self-activation.) |
| Activation according to instructions for use | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful performance in activating as instructed.) |
| Needle retraction after activation | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Also, under "Safety protection features": "Yes, after puncture the needle retracts automatically into the housing to prevent sharps injuries." (Successful retraction confirmed.) |
| Sterilization validation | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Specifically, "Sterilize by radiation SAL = $10^{-6}$" is stated for both new and predicate devices. |
| Packaging validation | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful packaging validation.) |
| Shelf-life validation | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." Specifically, "5 years" shelf life is stated for both new and predicate devices. |
| Biocompatibility testing | "The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device." (Implied successful biocompatibility testing.) |
Since the provided document is a 510(k) clearance for a physical medical device (Safety Lancet) and not an AI/software product, the following points are not applicable and cannot be answered from the provided text:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
January 25, 2023
Sarstedt AG & CO KG % Susan Smith Quality Manager Sarstedt, Inc. 1025 St. James Church Road Newton, North Carolina 28658
Re: K222801
Trade/Device Name: Safety Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: October 20, 2022 Received: October 24, 2022
Dear Susan Smith:
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,
Colin K. Chen -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) K22801
Device Name Safety-Lancet
Indications for Use (Describe)
Safety-Lancets with safety feature are used for single use capillary blood sampling.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| (5) 510(k) Summary | Prepared January 10, 2023 |
|---|---|
| Submission # K222801 | |
| Submission Sponsor | |
| SARSTEDT AG & CO KG | |
| Sarstedtstrasse 1 Nuembrecht North Rhine – Westphalia 51588 Germany | |
| Contact: Jochen Hoffmann | Phone: 49 2293 305 4100 |
Submission Correspondent
SARSTEDT, Inc.
| 1025 St. James Church Road, Newton, NC 28658 USA | |
|---|---|
| Contact: Susan Smith | Phone: 828-468-6655 |
Device identification
| Trade Name: | Safety Lancet® |
|---|---|
| Product Nomenclature: | Single use blood lancet with an integral sharps injury withprevention feature |
| Class II | |
| 79 FMK | |
| 21 CFR 878.4850 | |
| Legally Marketed Predicate Device | |
| Trade Name: | Safety Lancet® |
| Product Nomenclature: | Blood lancet |
|---|---|
| Class I | |
| 79 FMK |
21 CFR 878.4800
Device Description
The Safety Lancet consists of the following components: colorless plastic body, needle holder with needle or blade shaped lancing device, protective cap, carrier device, two springs, and the release button. The release button, the needle holder, and the protective cap are colored according to the variant available.
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The lancets are offered with different needle or blade shaped lancing devices, different sharpening and penetration depths, and accordingly in different colors. The lancets contain a safety feature. After puncture the needle retracts automatically into the housing to prevent sharps injuries.
| Itemnumber | Description | Specification | Color |
|---|---|---|---|
| 85.1015 | Safety-LancetMini 28G | Penetration depth:1,6 mm;Cross-section:$0,09858 mm^2$ | Image: Safety-Lancet Mini 28G color |
| 85.1016 | Safety-LancetNormal 21G | Penetration depth:1,8 mm;Cross-section: $0,4035 mm^2$ | Image: Safety-Lancet Normal 21G color |
| 85.1017 | Safety-LancetExtra 18G | Penetration depth:1,8 mm;Cross-section:$0,4680 mm^2$ | Image: Safety-Lancet Extra 18G color |
| 85.1018 | Safety-LancetSuperBlade 1,5 mm | Penetration depth:1,6 mm;Cross-section:$0,4639 mm^2$ | Image: Safety-Lancet Super color |
| 85.1019 | Safety-LancetNeonatalBlade 1,5 mm | Penetration depth:1,2 mm;Cross-section:$0,2574 mm^2$ | Image: Safety-Lancet Neonatal color |
Intended Use/Indications for Use
Safety-Lancets with safety feature are used for single use capillary blood sampling.
Specification
The products are intended for human use in a professional environment by qualified medical personnel.
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Technological characteristics comparison
| Comparisonitem | Safety Lancet | Safety Lancet |
|---|---|---|
| Manufacturer | SARSTEDT | SARSTEDT |
| 510(k) | submitted | Exempt Class I |
| Classification | FMK | FMK |
| Intended Use | Intended for single use capillaryblood sampling | Intended for single use capillaryblood sampling |
| User | qualified medical personnel inhospitals, clinics and referencelaboratories | qualified medical personnel inhospitals, clinics and referencelaboratories |
| Materialscontactingpatient | Housing - PPNeedle/blade cover - PSNeedle/blade - Stainless steelNeedle/blade lubricant - siliconePush button - PP | Housing - PPNeedle/blade cover - PSNeedle/blade - Stainless steelNeedle/blade lubricant - siliconePush button - PP |
| Components | Housing, Drive spring, Return spring, Lever, Needle/blade,Needle/blade cover, Pushbutton | Housing, Drive spring, Return spring, Lever, Needle/blade, Needle/bladecover, Push button |
| Devicecharacteristics | Specification28 G21 G18 GBlade 1,5 mmBlade 1,5 mm | Penetration1.6 mm1.8 mm1.8 mm1.6 mm1.2 mm |
| Safetyprotectionfeatures | Yes, after puncture the needleretracts automatically into thehousing to prevent sharpsinjuries. | Yes, after puncture the needleretracts automatically into thehousing to prevent sharps injuries. |
| Reusedurability | Single use | Single use |
| Shelf Life | 5 years | 5 years |
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| Sterilization method and SAL | Sterilize by radiationSAL = $10^{-6}$ | Sterilize by radiationSAL = $10^{-6}$ |
|---|---|---|
| Labeling | According to 21 CFR 801, 809, 830, 878.4850 | According to 21 CFR 801, a809, 830, 878.4800 |
Summary of non-clinical testing
Bench tests were conducted to verify that the proposed device met all design specifications and to prove that the device was substantially equivalent to the predicate device.
The design specification tests included:
- Aesthetics and correct assembly ●
- Inspection for self-activation
- Activation according to instructions for use ●
- Needle retraction after activation ●
The testing also included sterilization validation, packaging validation, shelf-life validation, and biocompatibility testing.
Conclusion
The Safety Lancet pre November 22, 2021 and the Safety Lancet described in this submission are physically and functionally the same. The non-clinical testing has shown that the Safety Lancet is as safe, as effective and performs as well as the legally marketed predicate device. The products will differ on the required labelling described in 21 CFR 878.4850.
§ 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.