(116 days)
Not Found
No
The device description details a purely mechanical and vacuum-assisted blood collection process. There is no mention of any computational or data-driven components that would suggest the use of AI or ML. The performance study focuses on the physical collection success rate.
No.
The document states that the device is "intended for obtaining microliter capillary whole blood samples," not for treating a condition or disease. It is a blood collection device.
No
Explanation: The device is intended for obtaining blood samples and not for diagnosing any condition. It is a blood lancing device, which is a tool used to collect samples that are then sent for diagnostic testing elsewhere.
No
The device description clearly outlines a physical, disposable blood lancet with mechanical components (spring, lancet assembly, button) and a vacuum mechanism for blood collection. It is a hardware device.
Based on the provided information, the Tasso+ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "for obtaining microliter capillary whole blood samples." This describes a device used for collecting a biological sample.
- Device Description: The description details the mechanism for lancing the skin and collecting blood into a tube. It focuses on the physical process of sample acquisition.
- Lack of Diagnostic Function: There is no mention of the device performing any analysis, testing, or interpretation of the blood sample itself. IVDs are designed to perform tests on biological samples to provide diagnostic information.
- Clinical Performance Data: The performance data focuses on the success rate of collecting the blood sample, not on the accuracy or performance of any diagnostic test.
The Tasso+ is a blood collection device, which is a different category of medical device than an IVD. It is used to obtain the sample that may then be used in an IVD test.
N/A
Intended Use / Indications for Use
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Product codes (comma separated list FDA assigned to the subject device)
FMK
Device Description
The Tasso+ device is a sterile, disposable blood lancet. After attachment of a compatible third-party collection tube, the backing is removed from the medical adhesive that is located on the skin side of the device is adhered, in position, to the skin by this adhesive backing.
The device is actuated by pressing the button, causing an energized spring to release and swing the lancet assembly containing a single stainless-steel lancet in an arching motion to create an incision. The lancet contacts the patient momentarily, less than one second, to create a single incision. The mechanism automatically positions the lancet in an inactive position after it has made the incision to prevent sharps injury or re-actuation.
In addition to deploying the lancet, the push of the button generates a slight vacuum to facilitate blood flow under gravity into the blood collection tube. The blood flows from the incision via an open channel in the base and into the compatible tube. The blood flow is one-way, from the skin to the tube, preventing blood re-exposure.
The user is instructed to stop blood collection after a maximum of five minutes of draw time or when the blood reaches the maximum volume fill indicator on the attached tube. The device is then peeled off the skin, and the compatible third-party tube is removed and capped for transport.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper arm
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
An assessment of clinical performance data for Tasso+ successfully demonstrated its ability to collect blood samples from the upper arm of human subjects according to the device labeling. Subjects self-collected their blood samples following the Tasso+ instructions for use. The devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval. The devices had a total success rate of 94.2% and demonstrated that they performed as intended with a compatible tube.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Total success rate of 94.2%
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration".
August 12, 2022
Tasso. Inc. Trish Kan Brown Director of Regulatory Affairs 1631 15th Ave W, Suite 105 Seattle, Washington 98119
Re: K221131
Trade/Device Name: Tasso+ Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: July 11, 2022 Received: July 15, 2022
Dear Trish Kan Brown:
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 Mav 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part
1
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,
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221131
Device Name Tasso+
Indications for Use (Describe)
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
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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3
510(k) Summary
1. Submitter
Tasso, Inc. 1631 15th Ave W, Suite 105 Seattle, WA 98119 USA
2. Contact Person
Trish Kan Brown Director of Regulatory Affairs Telephone: (206) 822-4186 x1063 E-mail: tkanbrown@tassoinc.com
3. Date Prepared
August 11, 2022
-
- Device / Marketing Trade Name Tasso+
- ਦੇ. Common / Usual Name Blood lancet, single-use
6. Classification
Regulatory Device Class: II General & Plastic Surgery Classification Panel:
| Classification Name | 21 CFR Number | Product Code |
|---|---|---|
| Blood Lancets | 878.4850 | FMK |
7. Predicate Device
Tianjin Huahong Technology Safety Lancet (K220370); Product Code: FMK
8. Device Description
The Tasso+ device is a sterile, disposable blood lancet. After attachment of a compatible third-party collection tube, the backing is removed from the medical adhesive that is located on the skin side of the device is adhered, in position, to the skin by this adhesive backing.
The device is actuated by pressing the button, causing an energized spring to release and swing the lancet assembly containing a single stainless-steel lancet in an arching motion to create an incision. The lancet contacts the patient momentarily, less than one second, to create a single incision. The mechanism automatically positions the lancet in an inactive position after it has made the incision to prevent sharps injury or re-actuation.
In addition to deploying the lancet, the push of the button generates a slight vacuum to facilitate blood flow under gravity into the blood collection tube. The blood flows from the
4
K221131
incision via an open channel in the base and into the compatible tube. The blood flow is one-way, from the skin to the tube, preventing blood re-exposure.
The user is instructed to stop blood collection after a maximum of five minutes of draw time or when the blood reaches the maximum volume fill indicator on the attached tube. The device is then peeled off the skin, and the compatible third-party tube is removed and capped for transport.
9. Intended Use / Indications for Use
The Tasso+ is a single-use blood lancing device intended for obtaining microliter capillary whole blood samples.
Basis for Substantial Equivalence 10.
Tasso+ is substantially equivalent to its predicate device with regards to intended use, technological characteristics, and safety and effectiveness. A comparison table is provided below.
| Predicate: | Application Device: | ||
|---|---|---|---|
| Characteristic | Safety Lancet | Tasso+ | |
| Tianjin Huahong Technology Co., Ltd. | Tasso, Inc. | ||
| (K220370) | (this 510(k) submission) | ||
| Indications for | |||
| Use | The safety lancet is intended for capillary | ||
| blood sampling. | The Tasso+ is a single-use blood lancing | ||
| device intended for obtaining microliter | |||
| capillary whole blood samples. | |||
| FDA Product | |||
| Code | FMK | FMK | |
| Prescription or | |||
| Over-The- | |||
| Counter | Over-The-Counter | ||
| Sample Type | |||
| Collected | Capillary whole blood | ||
| Lancing Device | Single lancet | ||
| Blood Flow | |||
| Facilitation | Palpation of incision | Slight vacuum maintained over the incision | |
| Puncture Site | |||
| Creation | |||
| Mechanism | Spring loaded linear incision that actuates | ||
| when device is pressed against skin | Torsion spring loaded arcing/swinging | ||
| incision that actuates when button is pressed | |||
| Number of Uses | Single use | ||
| Non-Reusability | |||
| Feature | Yes | Yes; self-locking mechanism after use | |
| Sharps Injury | |||
| Prevention | Cap pulled off before use to prevent | ||
| accidental actuation. | Button cover removed before use to prevent | ||
| accidental actuation. | |||
| Lancet retracts into body of device after | |||
| activation. | Lancet retracts into body of device after | ||
| activation. | |||
| Patient Contact | |||
| Materials | Lancet: stainless steel | ||
| Body and cap: ABS, PS | Lancet: stainless steel | ||
| Body/housing: PC-ABS | |||
| Sterile Device | Yes | Yes | |
| Collection | |||
| Accessories | Compatible third-party tube | Compatible third-party tube |
Non-Clinical Performance Data 11.
Tasso+ has been designed and evaluated to comply with the following applicable FDA-
5
K221131
recognized consensus standards. All verification and validation testing for Tasso+ confirms that product specifications are met and are equivalent in design and technological and performance characteristics as the predicate device.
- ANSI AAMI ISO 11137-1:2006/(R)2015 Sterilization of health care products Radiation Part ● 1: Requirements for development, validation, and routine control of a sterilization process for medical devices [Including: Amendment 1 (2013) and Amendment 2 (2019)]
- ANSI AAMI ISO 11607-1:2019 Packaging for terminally sterilized medical devices Part 1: ● Requirements for materials, sterile barrier systems and packaging systems
- ANSI AAMI ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ANSI AAMI ISO 15223-1:2016 Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements
- ASTM D7386-16 Standard Practice for Performance Testing of Packages for Single Delivery Systems
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and ● Systems
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical ● Devices
- ASTM F2096-11 (Reapproved 2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials ●
- ISTA 3A 2018 Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less ●
- ISO 23908 First edition 2011-06-11 Sharps injury protection Requirements and test methods -. Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
- . ANSI AAMI IEC 62366-1:2015+AMD1:2020(Consolidated Text) Medical devices - Part 1: Application of usability engineering to medical devices, including Amendment 1
Tasso+ is also in compliance with the special controls described in 21 CFR 878.4850(a)(2).
12. Clinical Performance Data
An assessment of clinical performance data for Tasso+ successfully demonstrated its ability to collect blood samples from the upper arm of human subjects according to the device labeling. Subjects self-collected their blood samples following the Tasso+ instructions for use. The devices demonstrated that the minimum acceptable volume collected was within the lower limit of the 90% confidence interval. The devices had a total success rate of 94.2% and demonstrated that they performed as intended with a compatible tube.
13. Conclusion
The technological differences do not pose any new questions of safety or efficacy. Bench and clinical performance data demonstrate that the subject device can perform as intended when used according to the labeling. Therefore, the Tasso+ device is substantially equivalent to the predicate device in terms of safety and effectiveness for the requested indications for use.