(235 days)
Not Found
No
The device description and performance studies focus on mechanical and biological safety features, with no mention of AI or ML.
No.
The device facilitates blood collection and prevents needlestick injuries, which are procedural and safety functions, not therapeutic treatments for a disease or condition.
No
This device is a blood collection tube holder that facilitates blood collection. Its primary function is to aid in the prevention of needlestick injuries and contaminated needle exposure during venous blood collection. While the collected blood may be used for diagnostic purposes, the device itself does not perform any diagnostic function; it is a tool for specimen collection, not analysis.
No
The device description clearly outlines a physical blood collection tube holder with an attached needle and a mechanical retraction mechanism. The performance studies focus on biocompatibility, mechanical testing, simulated use with healthcare workers, and sterilization validation, all indicative of a hardware device. There is no mention of software as a component or the primary function of the device.
Based on the provided information, the EasyPoint® Blood Collection Plus is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for venous blood collection and aiding in the prevention of needlestick injuries. It is a tool for collecting the sample, not for performing a diagnostic test on the sample itself.
- Device Description: The description focuses on the mechanics of blood collection, the safety features for preventing needlestick injuries, and the ability to collect multiple samples. It does not describe any components or functions related to analyzing or testing the blood.
- Lack of Diagnostic Function: An IVD device is specifically designed to perform tests on samples (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The EasyPoint® Blood Collection Plus does not perform any such tests. It is a collection device.
- Predicate Device: The predicate device listed (K982541 - Vacutainer® Eclipse™ Blood Collection Needle) is also a blood collection needle with a safety feature, not an IVD device.
In summary, the EasyPoint® Blood Collection Plus is a blood collection device with a safety feature, not a device that performs diagnostic testing on the collected blood.
N/A
Intended Use / Indications for Use
The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.
Product codes (comma separated list FDA assigned to the subject device)
JKA, FMI
Device Description
The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle.
The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.
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
May be used for blood collection for diagnostic purposes of any patient population with consideration given to patient size, per institutional protocol.
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)
Biocompatibility Testing: A Biological Safety Evaluation (BSE) of the EasyPoint® Blood Collection Plus was conducted in accordance with ISO 10993-1, ISO 14971, and the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1." It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity.
Mechanical Testing: Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure.
Simulated Use Study: A simulated use pre-market study was conducted to demonstrate through human factors validation testing that the EasyPoint® Blood Collection Plus device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario. The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality.
Sterilization Validation: Sterilization validation was performed according to ISO 11135 = "Sterilization of healthcare products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices." This revalidation to specifically address the addition of the EasyPoint® Blood Collection Plus demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10-6.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 862.1675 Blood specimen collection device.
(a)
Identification. A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Retractable Technologies, Inc. Becky Piroga Regulatory Affairs Manager 511 Lobo Lane Little Elm. Texas 75068
Re: K202325
Trade/Device Name: EasyPoint Blood Collection Plus Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA. FMI Dated: March 1, 2021 Received: March 9, 2021
Dear Becky Piroga:
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 (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.
James M. Simpson Jr
-57
for Paval Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name EasyPoint® Blood Collection Plus
Indications for Use (Describe)
The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 区 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K202325 510(k) SUMMARY EASYPOINT® BLOOD COLLECTION PLUS (21 CFR 807.92)
| I. SUBMITTER | Retractable Technologies, Inc.
511 Lobo Lane
Little Elm, TX 75068 |
|----------------------|---------------------------------------------------------------------------------|
| FDA Registration: | 1647137 |
| Phone: | 972-294-1010 |
| Fax: | 972-294-4400 |
| Contact Person: | Becky Piroga, Regulatory Affairs Manager |
| Date Prepared: | November 15, 2019 |
| II. DEVICE | |
| Name of Device: | EasyPoint® Blood Collection Plus |
| Common Name: | Blood collection tube holder with attached needle |
| Classification Name: | -Tubes, vials, systems, serum separators, blood collection (21
CFR 862.1675) |
| Regulatory Class: | II |
| Product Codes: | JKA, FMI |
| 510k Number: | K202325 |
IV. DEVICE DESCRIPTION
III. PREDICATE DEVICE
The EasyPoint® Blood Collection Plus is a blood collection tube holder with an attached needle, and is intended to facilitate blood collection from patients. The device contains a sharps injury prevention feature (needlestick prevention feature - chamber, utilizing automated retraction technology) which covers the entire needle when activated. The EasyPoint® Blood Collection Plus aids in the prevention of needlestick injuries during normal handling and disposal, and prevents re-use of a contaminated needle.
K982541 - Vacutainer® Eclipse™ Blood Collection Needle
The EasyPoint® Blood Collection Plus allows for multiple sample draws from a single venipuncture. After blood collection is complete, the retraction mechanism is activated and the device disassembles itself by retracting the contaminated needle into the safety chamber. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. The safety mechanism can be activated using one step and allows the user's hands to remain behind the sharp during activation.
V. INDICATIONS FOR USE
The EasyPoint® Blood Collection Plus is intended for use with evacuated blood collection tubes for venous blood collection, while aiding in the prevention of needlestick injuries and contaminated needle exposure,
The device contains a sharps injury prevention feature which covers the entire needle when activated. The safety mechanism allows the user to activate the needle retraction while the needle is still in the patient, preventing exposure to the contaminated needle. VI. COMPARISON TO THE PREDICATE DEVICE
4
| Feature | Subject Device:
EasyPoint® Blood
Collection Plus | Predicate Device:
Vacutainer® Eclipse™
Blood Collection Needle | Comparison |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification
Name | Hypodermic single lumen
needle | Hypodermic single lumen
needle | Same |
| Regulatory Class | II | II | Same |
| FDA Product Code | JKA, FMI | FMI | Same, with additional
category (blood collection) |
| Intended Use | Intended for use with
evacuated blood collection
tubes for venous blood
collection, while aiding in
the prevention of
needlestick injuries and
contaminated needle
exposure. | Designed for use with
Vacutainer® Blood
Collection Needle
Holders in performing
venipuncture to obtain
blood samples. | Same, except the
EasyPoint® Blood
Collection Plus is already
attached to a blood
collection tube holder (no
need for a separate
accessory device).
Comparison tests were
performed using
Vacutainer® Eclipse™
Blood Collection Needle
with Pre-attached Holder. |
| Indications for Use | May be used for blood
collection for diagnostic
purposes of any patient
population with
consideration given to
patient size, per
institutional protocol.
Single Use Only. Supplied
Sterile. | May be used for blood
collection for diagnostic
purposes. Recommends
referring to institutional
protocol for venipuncture
procedures; does not
restrict usage to a
particular patient
population.
Single Use Only.
Supplied Sterile. | Same. Neither provides
criteria for population-
specific use of the product.
Both products recommend
referring to institutional
protocol for appropriate
venipuncture procedures.
Both products are supplied
sterile and are indicated for
single use only. Both
products are indicated for
blood collection for
diagnostic purposes. |
| Needle Gauge Size
used in comparison
studies | 21G x 1 ¼" | 21G x 1 ¼" | Same |
| Additional Needle
Gauge Sizes Available | 22G x 1 ¼" | 22G x 1 ¼" | Same |
| | | | |
| Materials for
Components in
Common | Needle Cap:
Polypropylene | Needle Cap:
Polypropylene | Same except for needle
holder and needle adhesive. |
| | Needle Cannula:
304 Stainless Steel | Needle Cannula:
304 Stainless Steel | |
| | Needle Lubricant:
Silicone Lubricant | Needle Lubricant:
Silicone Lubricant | |
| | Needle Adhesive:
UV Cure Adhesive | Needle Adhesive:
Epoxy Resin | |
| | Needle Holder:
Polycarbonate | Needle Holder:
Polystyrene | |
| | Needle Rubber Sleeve:
Synthetic Polyisoprene
Rubber (not made with
natural rubber latex) | Needle Rubber Sleeve:
Synthetic Rubber (not
made with natural rubber
latex) | |
| | Tube Holder:
Polypropylene | Tube Holder:
Polypropylene | |
| Materials for
Components that
Differ | Retraction Spring:
304 Stainless Steel | Collar:
Polystyrene
Safety Shield:
Polypropylene | N/A |
| | Device Body:
Polypropylene | | |
| | Tube Holder Connector:
Polypropylene | | |
| Safety Mechanism | Automated Retraction
Technology | Hinged Safety Shield | The EasyPoint® Blood
Collection Plus utilizes a
retraction safety
mechanism, which retracts
the contaminated needle
into a safety chamber using
automated retraction
technology. The
Vacutainer® Eclipse™
Blood Collection Needle
utilizes a safety shield safety
mechanism, which covers
the contaminated needle
after use using a hinged
safety shield activated with
thumb pressure. |
| Sterilization Method | Ethylene Oxide | Radiation | The sterilization methods
are different, but both
provide the same level of
sterility assurance. Both
products, through validated
sterilization methods to their
respective ISO standards
(ISO 11135 and ISO |
| | | | 11137), guarantee a SAL of
10-6. |
| Biocompatibility | ISO 10993-1
Cytotoxicity, etc [list tests] | ISO 10993-1 | Same. Both products
conform to ISO 10993-1,
Biological evaluation of
medical devices –
Evaluation and testing
within a risk management
process. |
| Precautions and
Symbols Indicated on
Packaging | -Sterile (EO)
-Do not re-use
-Do not use if package is
damaged
-Not Made With Natural
Rubber Latex
-LOT number
-Expiration Date
-Non-toxic
-Non-pyrogenic
-Consult instructions for
use | -Sterile (R)
-Do not re-use
-Do not use if package is
damaged
-Not Made With Natural
Rubber Latex
-LOT number
-Expiration Date
-Keep away from sunlight
-Caution | Similar. Biocompatibility
and cytotoxicity testing has
been performed by
Retractable Technologies,
Inc. to validate the claims of
Non-toxic and Non-
pyrogenic. |
5
6
Additional information on performance and material comparison studies can be found in the body of this submission.
7
VII. PERFORMANCE DATA
Biocompatibility Testing
A Biological Safety Evaluation (BSE) of the EasyPoint® Blood Collection Plus was conducted in accordance with ISO 10993-1, ISO 14971, and the FDA Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993-1." It was found to be non-cytotoxic, a non-sensitizer, a non-irritant, nonpyrogenic, non-hemolytic, and to not produce acute systemic toxicity. Additional details and reports can be found in the body of this submission.
Mechanical Testing
Engineering and performance testing on the EasyPoint® Blood Collection Plus was performed according to applicable design requirements of ISO 7864 and ISO 9626. Performance tests were developed by Retractable Technologies, Inc. to measure the functionality (retraction) force, needle pullout force, rubber sleeve pullout force, needle cap separation force, puncture/penetration force, and to verify that the device does not leak under pressure. Additional details and reports can be found in the body of this submission.
Simulated Use Study
A simulated use pre-market study was conducted to demonstrate through human factors validation testing that the EasyPoint® Blood Collection Plus device performs safely and effectively when used by a variety of healthcare workers in a simulated use scenario. The study showed that the EasyPoint® Blood Collection Plus is comparable to currently legally marketed blood collection tube holders with regards to safety, ease of use. effective use, needlestick prevention, and device functionality. Additional details, including the final report from the pre-market study, can be found in the body of this submission.
Sterilization Validation
Sterilization validation was performed according to ISO 11135 = "Sterilization of healthcare products – Ethylene Oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices." The sterilization chamber and process used to sterilize the EasyPoint® Blood Collection Plus has been successfully used for many other products manufactured by Retractable Technologies, Inc. This revalidation to specifically address the addition of the EasyPoint® Blood Collection Plus demonstrated that the sterilization process continues to be effective and to meet the sterility assurance level (SAL) of 10t6. Additional details and reports can be found in the body of this submission.
VIII. CONCLUSION
Results of testing have demonstrated that the EasyPoint® Blood Collection Plus meets requirements for its intended use. The EasyPoint® Blood Collection Plus is substantially equivalent to its predicate device, the Vacutainer® Eclipse™ Blood Collection Needle, The intended uses are the same, the materials are effectively the same, and no new concerns regarding safety and effectiveness were raised during comparison testing.