(428 days)
No
The device description details a purely mechanical lancet for blood sampling, with no mention of computational or data processing capabilities that would involve AI/ML.
No.
The device is described as a lancet for obtaining capillary blood samples, which is a diagnostic procedure, not a therapeutic treatment.
No
This device is a lancet used to obtain a capillary blood sample, not to analyze it or provide a diagnosis. Its function is to pierce the skin, not to interpret biological data.
No
The device description clearly details a physical, sterile, single-use, disposable lancet with mechanical components (needles, housing, buttons, springs, etc.) for capillary blood sampling. It is a hardware device.
Based on the provided information, the NanoDrop Lancet is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is "to obtain a capillary blood sample." It explicitly says it "does not collect or transport such samples." IVD devices are used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device's function is solely to obtain the sample, not to analyze it or provide diagnostic information.
- Device Description: The description details a mechanical device for piercing the skin and creating a vacuum to facilitate blood flow. There are no components or processes described that would be involved in the in vitro analysis of a sample.
- Lack of IVD-related information: The document does not mention any aspects related to sample analysis, reagents, diagnostic targets, or any other elements typically associated with IVD devices.
In summary, the NanoDrop Lancet is a device used to collect a biological sample (blood), which is a necessary step for some IVD procedures, but it is not an IVD device itself.
N/A
Intended Use / Indications for Use
The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.
Product codes
FMK
Device Description
The Drawbridge Health NanoDrop Lancet Device is a sterile, single-use, disposable lancet for capillary blood sampling. The device incorporates two (2) stainless steel needles with blade tips to make two (2) small incisions in the skin. The device is made of a gray plastic housing base that has a molded outer rim and a bowl-shaped cavity. The outer rim is covered by a hydrogeladhesive to better attach the device to the skin, with a cover over the hydrogel adhesive pad for its protection. The bowl shape provides space for the skin to be drawn up as slight controlled vacuum pressure is applied, and for the needle blades to access the skin after piercing through a septum and vacuum chamber foil. There are two (2) clearly marked gray push buttons on the device:
- The gray button marked "I" is for activation of the vacuum; and
- The gray button marked "II" is for deployment of the needle blades.
There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container. The single model number is FD004.
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
Adults and Pediatrics. If user is under the age of 18, the lancet must be used by an adult or under the supervision of an adult
Intended User / Care Setting
Over-The-Counter Use
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
A clinical study was performed with the aim to evaluate the safety and use of the NanoDrop Lancet Device and to evaluate the user's opinion with regards to handling characteristics of the device as compared to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643). The study included thirty subject with two samples for each device (four samples per subject). All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm.
Non-clinical performance includes: Pain levels and preferred method of obtaining blood - User Study; Lancet Cut (Penetration) Depth; Applied Vacuum Lower Bound Test; Lancet Needle Blade Diameter; Device Length and Width; Device Redeployment Testing; Lancet Retraction Distance; Pull Force Testing of Needle from Holder; Sharps Injury Prevention Feature Drop Testing; Pull Force and Mechanical Testing of Permanent Plug; Permanent Plug Leak Test; Hydrogel Ring and Bloodborne Pathogen Barrier; USP-NF: 2020 Chapter Testing for Particulates in Solutions or Medical Devices.
Biocompatibility testing successfully completed: ISO 10993-1:2009 Biological Evaluation of Medical Devices-Part 1: Evaluation and testing within a risk management process; ISO 10993-3:2014 Biological Evaluation of Medical Devices- Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity; ISO 10993-4:2006 Biological Evaluation of Medical Devices-Part 4: Selection of tests for interaction with blood; ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Test for invitro cytotoxicty; ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Test for irritation and skin sensitization; ISO 10993-11:2006 Biological Evaluation of Medical Devices-Part 11: Test for systemic toxicity; Material-mediated Pyrogenicity; USP-NF 2018 USP USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method.
Sterilization/Shelf-life Testing/Shipping Testing: Sterilization Method: Radiation (electron beam), SAL 10-6. Standards applied: ANSI/AAMI/ISO 11137-1:2006/(R)15; A1:2013, ANSI/AAMI/ISO 11137-2: 2013, ANSI/AAMI/ISO 11137-3: 2017, ASTM F1980-16, ASTM 4169-16, ASTM F2096-11, ASTM F88/F88M-15.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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 of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 22, 2024
Drawbridge Health, Inc. Beth Thompson Sr. Regulatory Consultant, Lean RAQA 5949 Amberwood Dr. Naples, Florida 34110
Re: K223826
Trade/Device Name: NanoDrop Lancet Regulation Number: 21 CFR 878.4850 Regulation Name: Blood Lancets Regulatory Class: Class II Product Code: FMK Dated: January 26, 2024 Received: January 29, 2024
Dear Beth Thompson:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2024.02.22 Mark Trumbore, 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
2
Indications for Use
510(k) Number (if known) K223826
Device Name NanoDrop Lancet
Indications for Use (Describe)
The NanoDrop Lancet is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a red teardrop shape on the left, followed by the words "Drawbridge" and "Health" in black font. The word "Health" is located below the word "Drawbridge".
1. APPLICANT INFORMATION
| Submitter Information | |
|---|---|
| Company Name: | Drawbridge Health, Inc |
| Address: | 620 Omni Industrial Blvd |
| Summerville, SC 29486 | |
| Phone Number: | 1-631-897-5215 |
| Establishment Registration Number | 3015798231 |
| Primary Company Contact | |
| Name: | Jerome Scelza |
| Title: | Co-CEO |
| Phone Number: | 1-631-897-5215 |
| Email: | jscelza@dbhealth.com |
| Official Correspondent | |
| Name: | Beth Thompson |
| Title: | Sr. Regulatory Consultant |
| Phone Number: | 1-224-656-3620 |
| Email: | betht@leanraqa.com |
2. DATE OF PREPARATION
| Date of Preparation | January 26, 2024 |
|---|---|
| --------------------- | ------------------ |
3. DEVICE INFORMATION
| Device Name: | NanoDrop Lancet device |
|---|---|
| Common Name: | Blood Lancet |
| Classification Name: | Single use only blood lancet with an integral sharps |
| injury prevention feature | |
| Model(s): | FD004 |
| Regulation Number: | 21 CFR 878.4850(a) |
| Product Code: | FMK |
| Class: | Class II |
4. PREDICATE DEVICES
| Predicate Type | 510(k) Number | Name of Device | Name of Manufacturer |
|---|---|---|---|
| Primary Device | K223208 | Safety Lancet | Suzhou Zhenwu Medical |
| Co., Ltd. | |||
| Reference Device | K220643 | DropSafe Acti-Lance Safety | |
| Lancet | HTL-Strefa S.A. |
4
Image /page/4/Picture/0 description: The image shows the logo for Drawbridge Health. The logo consists of a red teardrop shape on the left, followed by the words "Drawbridge" in a bold, sans-serif font. Below "Drawbridge" is the word "HEALTH" in a smaller, sans-serif font. The logo is simple and modern, and the red teardrop shape likely represents blood, which is relevant to the company's focus on health and diagnostics.
5. DEVICE DESCRIPTION
The Drawbridge Health NanoDrop Lancet Device is a sterile, single-use, disposable lancet for capillary blood sampling. The device incorporates two (2) stainless steel needles with blade tips to make two (2) small incisions in the skin. The device is made of a gray plastic housing base that has a molded outer rim and a bowl-shaped cavity. The outer rim is covered by a hydrogeladhesive to better attach the device to the skin, with a cover over the hydrogel adhesive pad for its protection. The bowl shape provides space for the skin to be drawn up as slight controlled vacuum pressure is applied, and for the needle blades to access the skin after piercing through a septum and vacuum chamber foil. There are two (2) clearly marked gray push buttons on the device:
- The gray button marked "I" is for activation of the vacuum; and
- The gray button marked "II" is for deployment of the needle blades.
There is a yellow removable plastic locking feature to prevent accidental activation of the button that deploys the needle blades(gray button marked "II"). There is also a white vacuum chamber lid securely attached on top of the base, over the gray lancet enclosure, where the two needle blades are held in a clear plastic needle holder, along with the main spring and retraction spring, and into which they automatically retract after use, with no access to this gray lancet enclosure possible. This prevents the lancet from being used more than once, and it keeps the blades retracted for sharps injury prevention safety and for disposal. A permanent plug obstructs the port and mitigates unintended connection of a collection container.
The single model number is FD004.
6. INDICATIONS FOR USE
The NanoDrop Lancet device is intended for use to obtain a capillary blood sample. It does not collect or transport such samples.
| Device | Subject Device | Predicate Device | Remark | Reference
Device | Discussion |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------|------------|
| Device | Blood Lancet | Blood Lancet | Same | Blood Lancet | Same |
| Manufacturer | Drawbridge Health,
Inc | Suzhou Zhenwu
Medical Co. | Different | HTL-Strefa
S.A. | Different |
| 510(k) Number | K223826 | K223208 | Different | K220643 | Different |
| Product Code | FMK | FMK | Same | FMK | Same |
| Classification | Class II | Class II | Same | Class II | Same |
| Intended Use | Intended for capillary
blood sampling | Intended for capillary
blood sampling | Same | Intended for
capillary blood
sampling | Same |
| HEALTH | | | 510(k) Summary | | |
| Intended
Population | Adults and Pediatrics.
If user is under the
age of 18, the lancet
must be used by an
adult or under the
supervision of an
adult | Adults and Pediatrics. If
user is under the age of
18, the lancet must be
used by an adult or
under the supervision
of an adult | Same | Not stated | N/A |
| Number of Uses | Single use on one
person; no more than
one use | Single use on one
person; no more than
one use | Same | Single use on
one patient | Same |
| Prescription or
OTC Use | Over-the-counter | Over-the-counter | Same | Over-the
counter | Same |
| Needle Blade
gauge | 17G blades | Available in 21G and
18G blades | Similar | 17G blades | Same |
| Needle Blade
Diameter | 0.060in +/- 0.001in
(1.52mm +/-
0.025mm) | 21G: 0.800mm-
0.830mm
18G: 1.200mm-
1.300mm | Similar | Not stated | N/A |
| Needle Blade
Length | 0.500in +/- 0.002in | Unknown | Unknown | Not stated | N/A |
| Needle Blade
Penetration
Depth | 1.9-2.0 mm | 21G: 1.8, 2.0, 2.2, 2.4
mm
18G: 2.0, 2.2, 2.4 mm | Similar | Not stated | N/A |
| Usage | Single use only | Single use only | Same | Single use only | Same |
| Sterilization | Gamma radiation | Gamma radiation | Same | ISO 10993 | Same |
| Sharps Injury
Prevention
Feature | Only one puncture can
be made after the
protective lock and
adhesive cover are
removed and the push
buttons are activated
to start the vacuum
and to release the
blades. Both lancet
blades automatically
retract into the device
after activation. | The puncture function
can only be used after
the cap is pulled off.
Lancet retracts into the
device after activation. | Similar | Sharps Injury
Prevention
Feature and
Blade
Retraction | Similar |
| Biocompatibility | No cytotoxicity
No irritation
No skin sensitization
No acute systemic
toxicity
No pyrogens | No cytotoxicity
No irritation
No skin sensitization
No acute systemic
toxicity
No pyrogens | Same | ISO 10993 | Same |
| Clinical
Testing | Safety and
Performance study | None | Different | None | Different |
| Shelf life | 19 months | 5 years | Similar | 5 years | Similar |
7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
5
Drawbridge
6
The characteristics of the devices present no material differences in substantial equivalence as the gauge size and number of blades does not affect performance, the difference in method of activation does not affect performance, the penetration depth falls within the range of the predicate device, and the difference in shelf life does not affect performance. The devices are substantially equivalent to each other.
8. PERFORMANCE TESTING
-
8.1 Non-clinical performance
The following performance testing met all acceptance criteria. -
Pain levels and preferred method of obtaining blood - User Study
-
Lancet Cut (Penetration) Depth ●
-
Applied Vacuum Lower Bound Test ●
-
Lancet Needle Blade Diameter ●
-
Device Length and Width
-
Device Redeployment Testing
-
Lancet Retraction Distance
-
Pull Force Testing of Needle from Holder
-
Sharps Injury Prevention Feature Drop Testing
-
Pull Force and Mechanical Testing of Permanent Plug
-
Permanent Plug Leak Test
-
. Hydrogel Ring and Bloodborne Pathogen Barrier
-
USP-NF: 2020 Chapter Testing for Particulates in Solutions or Medical Devices
8.2 Biocompatibility
The following biocompatibility testing was successfully completed:
| 10993-1:
2009 | ISO | Biological Evaluation of Medical Devices-Part 1 :
Evaluation and testing within a risk management process |
|-------------------|-----------|--------------------------------------------------------------------------------------------------------------------------|
| 10993-3:
2014 | ISO | Biological Evaluation of Medical Devices- Part 3 : Tests for genotoxicity,
carcinogenicity, and reproductive toxicity |
| 10993-4:
2006 | ISO | Biological Evaluation of Medical Devices-Part 4 :
Selection of tests for interaction with blood |
| 10993-5:
2009 | ISO | Biological Evaluation of Medical Devices-Part 5 :
Test for invitro cytotoxicty |
| 10993-10:
2010 | ISO | Biological Evaluation of Medical Devices-Part 10:
Test for irritation and skin sensitization |
| 10993-
11:2006 | ISO | Biological Evaluation of Medical Devices-Part 11 :
Test for systemic toxicity; Material-mediated Pyrogenicity |
| USP-NF
2018 | USP | USP Limulus Amebocyte Lysate (LAL) Test - Kinetic-Turbidimetric Method |
Sterilization/Shelf-life Testing/Shipping Testing 8.3
| Sterilization Method | Radiation (electron beam) |
|---|---|
| NEW YORK | drawbridgehealth.com |
| 152 W 57th Street, 10th Floor | Info@dbhealth.com |
| New York NY 10017 |
7
Sterility Assurance Level
| 11137-
1:2006/(R)15;
A1:2013 | ANSI/AAMI/ISO | Sterilization of Healthcare Products-Radiation-Part 1 : Requirements for
development, validation and routine control of a sterilization process for
medical devices |
|------------------------------------|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 11137-2: 2013 | ANSI/AAMI/ISO | Sterilization of Healthcare Products-Radiation-Part 2 : Establishing the
radiation dose |
| 11137-3: 2017 | ANSI/AAMI/ISO | Sterilization of Healthcare Products-Radiation-Part 3 : Guidance on
dosimetric aspects |
| F1980-16 | ASTM | Standard Guide for Accelerated Aging of Sterile Medical Device Packages |
| 4169-16 | ASTM | Standard Practice for Performance Testing of Shipping Containers and
System |
| F2096-11 | ASTM | Standard Test Method for Detecting Gross Leaks in Medical Packaging by
Internal Pressurization (bubble test) |
| F88/F88M-15 | ASTM | Standard Test Method for Seal Strength of Flexible Barrier Materials |
SAL 10-6
8.4 Animal and Clinical performance data
No animal study is included in this submission.
A clinical study was performed with the aim to evaluate the safety and use of the NanoDrop Lancet Device and to evaluate the user's opinion with regards to handling characteristics of the device as compared to a comparable cleared OTC FMK fingerstick lancet (Acti-Lance K220643). The study included thirty subject with two samples for each device (four samples per subject). All acceptance criteria were met, supporting safe and effective use of the NanoDrop Device unsupervised and self-administered by adults on the upper arm.
9. CONCLUSION
The conclusions drawn from the clinical and nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device. They are substantially equivalent to each other.