(337 days)
No
The device description and performance studies focus on the physical components and biological/mechanical testing of a blood collection set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
Explanation: The device is intended for the collection of venous blood samples for diagnostic purposes and protection against needle stick injury, not for treating any medical condition.
No
Explanation: The device is a blood collection set and does not perform any diagnostic function. It is used to obtain blood samples, which can then be used for diagnostic tests, but the collection device itself is not diagnostic.
No
The device description clearly outlines physical components (needle, tubing, safety shield, holder) and the performance studies focus on physical characteristics (biocompatibility, sterilization, seal strength, etc.), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the collection of venous blood. While the collected blood may be used for in vitro diagnostic testing, the device itself is solely for the collection process.
- Device Description: The description focuses on the physical components and their function in obtaining a blood sample and preventing needle stick injury. It does not describe any components or processes that analyze or test the blood sample.
- Lack of IVD Characteristics: The description does not mention any reagents, assays, or analytical methods that are characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body (like blood) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is a tool for obtaining the specimen, not for performing the diagnostic test itself.
N/A
Intended Use / Indications for Use
The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
Product codes (comma separated list FDA assigned to the subject device)
JKA
Device Description
The Eclipse Blood Collection Set is a winged blood collection needle with flexible tubing intended for venipuncture to obtain blood samples. It is provided with a safety shield for covering the used venipuncture needle prior to disposal to aid in the prevention of needle stick injury if manually activated after the blood draw. For blood collection, the set also includes a blood collection holder for connection to vacuum-based collection vials
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rx Only: Licensed healthcare practitioners or individuals directed by practitioners
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)
The Eclipse Blood Collection Set was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria.
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.
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.
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October 26, 2022
Eclipse Medcorp LLC Julie Summerville Sr. Director of Product Management 5916 Stone Creek Drive Suite #120 The Colony, Texas 75056
Re: K213690
Trade/Device Name: Eclipse Blood Collection Set Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: September 27, 2022 Received: September 27, 2022
Dear Julie Summerville:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR
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- 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 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.
David Wolloscheck, Ph.D. For Paval Patel 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
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Indications for Use
510(k) Number (if known) K213690
Device Name Eclipse Blood Collection Set
Indications for Use (Describe)
The Eclipse Blood Collection Set with holder is intended to be used with vacuum blood collection tube for the collection of venous blood. The safety shield is intended to aid in the protection against accidental needle stick injury.
| 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) |
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This 510K Summary of safety and effectiveness for the Eclipse Blood Collection Set is submitted in accordance with the requirements of the SMDA 1990, 21 CFR 807.92(c) and following guidance concerning the organization and content of a 510K summary.
| Applicant: | Eclipse MedCorp, LLC |
|---|---|
| Address: | 5916 Stone Creek Drive |
| Suite 120 | |
| The Colony, TX 75056 USA | |
| Establishment Number: | 3009032449 |
| Contact Person: | Julie Summerville |
| Telephone: | |
| Email: | 972-380-2911 |
| jsummerville@eclipsemed.com | |
| Preparation Date: | October 26, 2022 |
| Device Trade Name: | Eclipse Blood Collection Set |
| Common Name: | Blood Collection Serum Separators, Systems, Vials, Tubes |
| Regulation Name: | Blood specimen collection device |
| Regulation Number: | 21 CFR 862.1675 (Product Code: JKA) |
| Predicate Device: | K200027 Blood Collection Needle |
| Reference Device: | K151991 Safelock Disposable Blood Collection Set |
| The reference device is included in this submission to | |
| demonstrate compliance to ISO 23908:2011 Sharps injury | |
| protection-Requirements and test methods. The sharps | |
| safety protection for the Eclipse Blood Collection Set is | |
| identical to the Safelock Disposable Blood Collection Set. | |
| Regulatory Class: | Class II Prescription |
| Device Description: | The Eclipse Blood Collection Set is a winged blood collection |
| needle with flexible tubing intended for venipuncture to | |
| obtain blood samples. It is provided with a safety shield for | |
| covering the used venipuncture needle prior to disposal to aid | |
| in the prevention of needle stick injury if manually activated | |
| after the blood draw. For blood collection, the set also | |
| includes a blood collection holder for connection to vacuum- | |
| based collection vials | |
| Indications for Use: | The Eclipse Blood Collection Set with holder is intended to be |
| used with vacuum blood collection tube for the collection of | |
| venous blood. The safety shield is intended to aid in the | |
| protection against accidental needle stick injury. | |
| Performance Testing | |
| Support: | The following performance data was provided in support of |
| the substantial equivalence determination: |
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The Eclipse Blood Collection Set was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria.
Biocompatibility:
Biocompatibility was evaluated on the final, finished device per the FDA guidance titled Use of International Standard ISO 10993-1 "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" – Guidance for Industry and Food and Drug Administration Staff issued in September 2020 with the following endpoints:
- Cytotoxicity (ISO 10993-5:2009)
- Sensitization (ISO 10993-10:2010) ●
- Irritation (ISO 10993-10:2010)
- Acute Systemic Toxicity (ISO 10993-11:2017) ●
- Material Mediated Pyrogenicity (ISO 10993-11:2017, USP 41 NF 36:2018, Pyrogen Test
- Hemocompatibility (Coagulation, Platelets and Hemolysis) (ISO 10993-4:2017)
Performance Data:
Performance testing was evaluation per the International Standard ISO 80369-7:2016 and ISO 80369-20:2015.
Sterilization and Shelf Life:
Ethylene oxide sterilization per ISO 11135-1:2014, ISO11737-1:2018; ISO 11737-2: 2009; ISO 10993-7:2008. The Sterility Assurance Level (SAL) is 10-6.
Sterilization, Shelf Life/Package Integrity in accordance with the following standards: ASTM-F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices; ASTM-F1886-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection; ASTM-F88/F88M-15, Standard Test Method for Seal Strength of Flexible Barrier Materials; ANSI/AAMI/ISO 11607-1: 2019, Packaging for Terminally Sterilized Medical Devices Part 1: Requirements for Materials, Sterile Barrier Systems and Packaging Systems; ASTM F2096-11 (2019), Standard Test Method for Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization (Bubble Leak); Real time aging studies are being conducted ambient conditioned storage temperatures for a period of 730 days (2 years). Upon completion of real time aging, half of
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the samples will undergo label inspection for overall adhesions and legibility, and seal strength tests per ASTM F88/F88M-15. The other half of the samples will undergo visual inspection per ASTM F1886-16 and bubble leak testing per ASTM F2096-11.
Clinical Study: Not applicable
Technological Characteristics and Comparison to the Predicate Device:
| | Subject Device:
Eclipse Blood
Collection Set | Predicate Device:
Safety Blood
Collection Needle
with/without Holder | Comparison |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) | K213690 | K200027 | N/A |
| Manufacturer | Eclipse MedCorp, LLC
The Colony, TX, U.S.A | Jiangsu Caina Medical
Co., Ltd.
Jiangsu, China | N/A |
| Device Class | Class II | Class II | Same |
| Product Code | JKA | JKA | Same |
| Regulation Number | 21 CFR 862.1675 | 21 CFR 862.1675 | Same |
| Regulation Name | Blood specimen
collection device | Blood specimen
collection device | Same |
| Indications for Use /
Intended Use | The Eclipse Blood
Collection Set with
holder is intended to be
used with vacuum blood
collection tube for the
collection of venous
blood. The safety shield
is intended to aid in the
protection against
accidental needle stick
injury. | The Safety Blood
Collection Needle
with/without Holder is
intended to be used with
vacuum blood collection
tube for the collection of
venous blood. The safety
shield is intended to aid
in the protection against
accidental needle stick
injury.
The Luer access device-
holder with preattached
multiple sample adapter
is a sterile, non-invasive
device used to connect
devices with male or
female luer connectors to
blood collection tubes for
the collection of blood | Different
The Eclipse Blood
Collection set does
not include the
preattached adapter
therefore this is
excluded from the
indication for use
for the subject
device. |
| | Subject Device:
Eclipse Blood
Collection Set | Predicate Device:
Safety Blood
Collection Needle
with/without Holder | Comparison |
| Intended Users | Rx Only: Licensed
healthcare
practitioners or
individuals directed by
practitioners | Rx Only: Licensed
healthcare
practitioners or
individuals directed by
practitioners | Same |
| Needle Gauge for
Butterfly Needle | 23G | 20G - 23G | Different |
| Needle Length for
the Butterfly Needle | 19.5mm | 25.4mm
31.75mm
38.1mm | Different |
| Needle Gauge for
Tube Holder Needle | 21G | 18G-27G | Different |
| Needle Length for
Tube Holder Needle | 23.8mm with the
exposed portion
15mm | 23.8mm with the
exposed portion 15mm | Same |
| Tube Holder volume | 22ml | 22ml | Same |
| Tube Holder
function | Hold tube in place
during blood draw | Hold tube in place
during blood draw | Same |
| Adapter | Luer | Luer | Same |
| Needle Safety Shield | Protective sliding cap | Protective hinge shield | Different but same
as reference
device |
| Configuration and
Materials | Protective Cover of
Butterfly Needle –
Polypropylene
Rubber Sleeve – Isoprene
Rubber | Non-patient Needle Cap
– Polypropylene
Rubber Sleeve - Case
Gather Isoprene
Rubber | Same |
| | Patient Needle Tube –
Stainless Steel | Patient Needle Tube –
Stainless Steel | |
| | Tube Holder Needle –
Stainless Steel | Needle Tube – Stainless
Steel | |
| | Luer lock Male Hub –
MABS | Luer Lock Male Hub –
MABS | |
| | Tubing – PVC | Tubing – PVC | |
| | Safety Shield –
Polypropylene | Safety Shield –
Polypropylene | |
| | Subject Device:
Eclipse Blood
Collection Set | Predicate Device:
Safety Blood
Collection Needle
with/without Holder | Comparison |
| | *Tube Holder –
Polypropylene | Tube Holder –
Polypropylene | |
| | Lubricant -
Polydimethylsiloxane | Lubricant -
Polydimethylsiloxane | |
| | *NOTE: for the Eclipse
device this is also called
the Transfer Device | | |
| Sterilization Method | Ethylene Oxide (EtO)
Gas Sterilization | Ethylene Oxide (EtO)
Gas Sterilization | Same |
| Sterility | Meets the SAL of 10-6
per ISO 11135-2014 | Meets the SAL of 10-6
per ISO 11135-2014 | Same |
| Packaging | Tyvek Pouch | Tyvek Pouch | Same |
| Use | Single Use | Single Use | Same |
| Performance | Complies with: | Complies with: | |
| | ISO 9626 | ISO 9626 | |
| | ISO 7864 | ISO 7864 | Same |
| | ISO 80369-7 | ISO 80369-7 | |
| Biocompatibility | Tested to ISO 10993 | Tested to ISO 10993 | Same |
| Shelf Life | 2 years | 2 years | Same |
| Endotoxin Limit |