(117 days)
Not Found
No
The summary describes a mechanical lancing device and does not mention any AI or ML components or functionalities.
No.
The device is used to obtain a blood sample, which is a diagnostic purpose, not a therapeutic one.
No
The device is used to obtain a blood sample, which is a step in the diagnostic process, but the device itself does not analyze the sample or provide a diagnosis. Its function is solely for sample collection.
No
The device description explicitly states it is a "Handheld, battery powered electronic lancing system," indicating it is a hardware device.
Based on the provided information, the L1 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "obtain a capillary blood sample." This is a device used to collect a sample, not to test or analyze it.
- Device Description: It's described as an "automatic blood lancet device." Lancets are tools for obtaining blood, not for performing diagnostic tests.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, measurement, or interpretation of the blood sample. It simply facilitates the collection.
- Comparison to Predicate: The predicate device is also a "Lancet Device," further indicating its function is sample collection.
IVD devices are specifically designed to perform tests on samples (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The L1 System's function is solely to provide the sample for such testing, which would be performed by a separate IVD device (like a blood glucose meter).
N/A
Intended Use / Indications for Use
The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.
Product codes
FMK
Device Description
Handheld, battery powered electronic lancing system for home use by individuals and caregivers to obtain blood samples.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home use by individuals and caregivers
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
Testing performed under the Design Control Process verified that the L1 System performed according to specifications and is in compliance with all applicable performance standards.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 shows the logo for Pelikan Technologies. The logo features the company name in bold, black letters. A black circle separates the two words. Below the company name is a black, curved shape that resembles a bird's wing.
Image /page/0/Picture/1 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the letter 'o', then the numbers '2', '4', '1', '7', and ends with the letter 'o'. The characters are handwritten and appear to be on a white background.
510(k) Summary L1 System Pelikan Technologies, Corp.
APR 1 4 2003
Prepared December 6, 2002
| Product Name: | L1 System |
|---|---|
| Manufacturer: | Pelikan Technologies, Corp. |
| Generic Name | Blood lancet |
| Classification Name: | Manual surgical device for general use; blood lancet (Class I); |
| Classification code: FMK; 21 CFR 878.4800 | |
| Contact Person: | Jack S. Green, CQM |
| Quality Assurance Manager | |
| Pelikan Technologies, Corp. | |
| 1072 East Meadow Circle | |
| Palo Alto, California 94303 |
A. Legally Marketed Predicate Device
The L1 System is substantially equivalent to the SoftTouch Lancet Device manufactured by Boehringer Mannheim Corporation (K931258).
B. Device Description
Handheld, battery powered electronic lancing system for home use by individuals and caregivers to obtain blood samples.
C. Intended Use
The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.
D. Substantial Equivalence
The L1 system is substantially equivalent to the intended use and technological characteristics of the Soft Touch predicate device.
E. Performance Data
Testing performed under the Design Control Process verified that the L1 System performed according to specifications and is in compliance with all applicable performance standards.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2003
Mr. Jack S. Green, CQM Ouality Assurance Manager Pelikan Technologies Corporation 1072 East Meadow Circle Palo Alto, California 94303
Re: K024170
Trade/Device Name: L1 System Regulation Number: 21 CFR 878.4800 Regulation Names: Manual surgical instrument for general use Regulatory Class: I Product Codes: FMK Dated: March 4, 2003 Received: April 1, 2003
Dear Mr. Green:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Mr. Jack S. Green, CQM
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely vours.
Sincerely yours,
Mark n Millerson
Celia M. Witten, Ph.D., M.D. Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Pelikan Technologies. The logo consists of the word "PELIKAN" in bold, followed by a black dot and the word "TECHNOLOGIES" in a smaller font. Below the text is a stylized graphic element, possibly representing a pelican's beak or wing, in solid black.
Indications for Use Statement
510(k) Number (if known): ΚοΣΑΙ ΠΟ
Device Name: L1 System
Indications For Use: The L1 System is an automatic blood lancet device used to obtain a capillary blood sample.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence Of CDRH, Office Of Device Evaluation (ODE) | |||||
|---|---|---|---|---|---|
| Prescription Use |
(Per 21CFR 801) | | OR | Over-The-Counter Use
__________ | | |
Mark N Milburn
Division Sign-Off Teneral, Restorative and Nearological Devices
510(k) Number K024170