(120 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device is used to initiate capillary blood flow for obtaining a blood sample, which is a diagnostic procedure, not a therapeutic treatment.
No
The device is an automated skin incision device used to collect capillary blood for obtaining a blood sample. It is not used to diagnose a medical condition.
No
The device description clearly states it is an "automated skin incision device" that uses a "surgical blade" enclosed in a "plastic housing" and deployed by a "trigger." These are physical hardware components, not software.
Based on the provided information, the Tenderfoot device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "initiate capillary blood flow via a heel stick with infants and toddlers." This describes a procedure to obtain a sample, not a test performed on a sample to diagnose a condition.
- Device Description: The description focuses on the mechanical function of the device to make an incision and collect blood. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The description doesn't mention reagents, test strips, analytical methods, or any other elements typically associated with in vitro diagnostic devices.
Tenderfoot is a device used to collect a biological sample (blood), which can then be used in an IVD test, but the device itself is not the diagnostic test.
N/A
Intended Use / Indications for Use
Tenderfoot is a sterile incision device intended to initiate capillary via a heel stick with infants and toddlers.
For medical device use. For healthcare professional use, prescription only.
Product codes
FMK
Device Description
Tenderfoot is an automated skin incision device used to collect capillary blood from infants and toddlers by heel stick. The device produces an arc-like incision at a controlled depth to provide blood flow for obtaining a blood sample. The incision is made by a surgical blade that is completely enclosed in a plastic housing and deployed by pressing a trigger. Following deployment, the blade permanently retracts within the housing, rendering the device inoperable for further use.
Tenderfoot is provided as a sterile, single-use disposable device intended for use by healthcare professionals only. Sterilization is achieved by gamma irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heel
Indicated Patient Age Range
infants and toddlers
Intended User / Care Setting
healthcare professional use, prescription only.
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)
Nonclinical bench testing was performed for cut depth, cut length, trigger activation, and blade retraction before and after stress conditions, such as simulated distribution and aging. The testing met all acceptance criteria.
Biocompatibility evaluation for Tenderfoot was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing was successfully completed for the following endpoints:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute systemic toxicity
- Material-mediated pyrogen testing ●
- Hemocompatibility ●
Sterilization by gamma irradiation was validated per ISO 11137-1 and demonstrated a Sterility Assurance Level (SAL) of 10-6.
Sterile barrier packaging testing was conducted for packaging performance and stability in accordance with ISO 11607-1. Package integrity tests included:
- Visual inspection of seal width
- Seal strength (ASTM F88/F88M)
- Gross leaks (ASTM F2096) ●
- . Microbial barrier (ASTM F1608)
A packaging shelf life of 4 years was established through accelerated aging per ASTM F1980.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.
March 2, 2023
Accriva Diagnostics, Inc. Wenni Haley Senior Principal Specialist, Regulatory Affairs 6260 Sequence Drive San Diego, California 92121
Re: K223352
Trade/Device Name: Tenderfoot Regulation Number: 21 CFR 878.4850 Regulation Name: Blood lancets Regulatory Class: Class II Product Code: FMK Dated: November 1, 2022 Received: November 2, 2022
Dear Wenni Haley:
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
1
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
2
Accriva Diaqnostics, Inc. Tenderfoot - Special 510(k) K223352/S001
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K223352
Device Name
Tenderfoot Newborn, Tenderfoot Micro-Preemie, Tenderfoot Preemie, Tenderfoot Toddler
Indications for Use (Describe)
Tenderfoot is a sterile incision device intended to initiate capillary via a heel stick with infants and toddlers.
For medical device use. For healthcare professional use, prescription only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. SUBMITTER
| Applicant: | Accriva Diagnostics, Inc.
6260 Sequence Drive
San Diego, CA 92121
USA
Establishment Registration Number: 3002721930 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Application
Correspondent: | Wenni Haley
Senior Principal Specialist, Regulatory Affairs
Phone: 858-263-2322
Email: whaley@werfen.com |
| Date Prepared: | March 1, 2023 |
II. DEVICE
| Trade Name: | Tenderfoot |
|---|---|
| Common Name: | Heel Incision Device |
| Classification Name: | Single use only blood lancet with an integral sharps injury prevention feature |
| Regulation Number: | 21 CFR 878.4850 |
| Regulatory Class: | Class II |
| Product Code: | FMK |
| Review Panel: | General and Plastic Surgery (79) |
III. PREDICATE DEVICE
| Primary Predicate: | Tenderfoot (K883968), Product Code: FMK |
|---|---|
| Additional Predicate: | Tenderfoot (K911997), Product Code: FMK |
IV. DEVICE DESCRIPTION
Tenderfoot is an automated skin incision device used to collect capillary blood from infants and toddlers by heel stick. The device produces an arc-like incision at a controlled depth to provide blood flow for obtaining a blood sample. The incision is made by a surgical blade that is completely enclosed in a plastic housing and deployed by pressing a trigger. Following deployment, the blade permanently retracts within the housing, rendering the device inoperable for further use.
4
Tenderfoot is provided as a sterile, single-use disposable device intended for use by healthcare professionals only. Sterilization is achieved by gamma irradiation.
Tenderfoot is offered in four models covering a range of incision depths sized for different infant populations: Micro-Preemie, Preemie, Newborn, and Toddler (see table below).
| Tenderfoot Model | Incision Depth | Incision Length | Color |
|---|---|---|---|
| Micro-Preemie | 0.65 mm | 1.40 mm | Blue |
| Preemie | 0.85 mm | 1.75 mm | White |
| Newborn | 1.00 mm | 2.50 mm | Blue/Pink |
| Toddler | 2.00 mm | 3.00 mm | Pink |
Tenderfoot is not marketed with accessories or as part of a system.
V. INDICATIONS FOR USE
Tenderfoot is a sterile incision device intended to initiate capillary blood flow via a heel stick with infants and toddlers.
For medical device use. For healthcare professional use, prescription only.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
A detailed comparison between the predicate, the currently marketed Tenderfoot device (K883968 and K911997), and the subject Tenderfoot device is provided in the table below to demonstrate substantial equivalence.
| Characteristic | Predicate
Tenderfoot (K883968, K911997) | Subject Device
Tenderfoot (this submission) |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Similarities | | |
| Indications for Use /
Intended Use | Tenderfoot is a sterile incision device
intended to initiate capillary blood
flow via a heel stick with infants and
toddlers for use in diagnostic testing.
For medical device use. For healthcare
professional use, prescription only. | Tenderfoot is a sterile incision device
intended to initiate capillary blood
flow via a heel stick with infants and
toddlers.
For medical device use. For healthcare
professional use, prescription only. |
| Characteristic | Predicate | Subject Device |
| | Tenderfoot (K883968, K911997) | Tenderfoot (this submission) |
| Principle of
Operation | Incision made by a spring-loaded,
cam-driven surgical steel blade
moving in a single sweeping motion,
actuated by pressing a trigger. | Incision made by a spring-loaded,
cam-driven surgical steel blade
moving in a single sweeping motion,
actuated by pressing a trigger. |
| Sharps Injury
Prevention Features | 1. Blade permanently retracts
following deployment.
2. Housing completely encloses the
blade and prevents finger access.
3. Detachable trigger guard prevents
accidental/premature actuation.
4. Indicator arrow indicates exit path
of the blade.
5. Device can be activated with a
single hand.
6. Trigger remains visibly depressed
to show device has already been
activated. | 1. Blade permanently retracts
following deployment.
2. Housing completely encloses the
blade and prevents finger access.
3. Detachable trigger guard prevents
accidental/premature actuation.
4. Indicator arrow indicates exit path
of the blade.
5. Device can be activated with a
single hand.
6. Trigger remains visibly depressed
to show device has already been
activated. |
| Incision Profiles
(Depth/Length) | Micro-Preemie: 0.65 mm / 1.40 mm
Preemie: 0.85 mm / 1.75 mm
Newborn: 1.00 mm / 2.50 mm
Toddler: 2.00 mm / 3.00 mm | Micro-Preemie: 0.65 mm / 1.40 mm
Preemie: 0.85 mm / 1.75 mm
Newborn: 1.00 mm / 2.50 mm
Toddler: 2.00 mm / 3.00 mm |
| Housing Colors | Micro-Preemie: Blue
Preemie: White
Newborn: Blue/Pink
Toddler: Pink | Micro-Preemie: Blue
Preemie: White
Newborn: Blue/Pink
Toddler: Pink |
| Housing
Dimensions | Width: 1.3 in
Height: 1.2 in (excluding trigger
guard)
Depth: 0.5 in | Width: 1.3 in
Height: 1.2 in (excluding trigger
guard)
Depth: 0.5 in |
| Incision Blade
Design | Double-honed surgical blade | Double-honed surgical blade |
| Materials | Patient-Contacting
- Housing: Polystyrene
- Surgical Blade: Stainless steel | Patient-Contacting
- Housing: Polystyrene
- Surgical Blade: Stainless steel |
| | Non-Patient Contacting - Cam follower:
Polycarbonate/acrylic alloy - Torsion Spring: Stainless steel
- Trigger: Polystyrene | Non-Patient Contacting
- Cam follower:
Polycarbonate/acrylic alloy - Torsion Spring: Stainless steel
- Trigger: Polystyrene |
| | 6. Trigger Guard: Polystyrene | 6. Trigger Guard: Polystyrene |
| Characteristic | Predicate
Tenderfoot (K883968, K911997) | Subject Device
Tenderfoot (this submission) |
| Packaging System | Primary (sterile barrier) - Blister Pack Tray: Polyethylene
terephthalate (PETG) - Lid: Tyvek
Secondary - Box: Clay-coated news back | Primary (sterile barrier)
- Blister Pack Tray: Polyethylene
terephthalate (PETG) - Lid: Tyvek
Secondary - Box: Clay-coated news back |
| Packaging (Boxed)
Configurations | Micro-Preemie: 50 pack
Preemie: 50 pack, 200 pack, 1000
pack
Newborn: 50 pack, 200 pack, 1000
pack
Toddler: 50 pack | Micro-Preemie: 50 pack
Preemie: 50 pack, 200 pack, 1000
pack
Newborn: 50 pack, 200 pack, 1000
pack
Toddler: 50 pack |
| Biocompatibility | Conforms to ISO 10993-1 | Conforms to ISO 10993-1 |
| Sterilization | Gamma irradiation
Sterility Assurance Level (SAL) of
10-6 | Gamma irradiation
Sterility Assurance Level (SAL) of
10-6 |
| Number of Uses | Single use only | Single use only |
| Shelf Life | 4 years | 4 years |
| Differences | | |
| Labeling | Does not contain all labeling
information required by the special
controls under 21 CFR
878.4850(a)(2). | Contains all labeling information
required by the special controls under
21 CFR 878.4850(a)(2). |
5
Accriva Diagnostics, Inc.
Tenderfoot - Special 510(k)
6
VII. PERFORMANCE DATA
The following nonclinical performance data were provided in support of the substantial equivalence determination and compliance with the special controls described in 21 CFR 878.4850(a)(2).
Performance Testing - Bench
Nonclinical bench testing was performed for cut depth, cut length, trigger activation, and blade retraction before and after stress conditions, such as simulated distribution and aging. The testing met all acceptance criteria.
7
Biocompatibility Testing
Biocompatibility evaluation for Tenderfoot was conducted in accordance with the FDA Guidance "Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 "Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing was successfully completed for the following endpoints:
- . Cytotoxicity
- Sensitization ●
- Irritation ●
- Acute systemic toxicity
- Material-mediated pyrogen testing ●
- Hemocompatibility ●
Sterilization and Shelf Life
Sterilization by gamma irradiation was validated per ISO 11137-1 and demonstrated a Sterility Assurance Level (SAL) of 10-6.
Sterile barrier packaging testing was conducted for packaging performance and stability in accordance with ISO 11607-1. Package integrity tests included:
- Visual inspection of seal width
- Seal strength (ASTM F88/F88M)
- Gross leaks (ASTM F2096) ●
- . Microbial barrier (ASTM F1608)
A packaging shelf life of 4 years was established through accelerated aging per ASTM F1980.
VIII. CONCLUSIONS
Based on the information provided in this submission, Accriva Diagnostics concludes that the subject device, Tenderfoot, is substantially equivalent to the predicate device (K883968 and K911997). The labeling differences between the subject and predicate do not raise new concerns of safety and effectiveness.