(337 days)
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 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
The provided text is a U.S. FDA 510(k) summary for the Eclipse Blood Collection Set. It describes the device's characteristics and its comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain the detailed information requested regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment for a diagnostic AI device.
The document states: "The Eclipse Blood Collection Set was tested for validation and verification of functions based on risk analysis and the results passed predetermined acceptance criteria." However, it does not specify what those predetermined acceptance criteria were or present a table comparing them to reported device performance.
It also mentions various types of performance testing, such as biocompatibility, performance data (per ISO 80369-7:2016 and ISO 80369-20:2015), and sterilization/shelf-life testing against relevant ISO and ASTM standards. While these indicate tests were performed to ensure the device meets safety and functionality standards relevant to its type, they are largely about manufacturing and material safety, not diagnostic performance or AI model validation.
Crucially, the document explicitly states: "Clinical Study: Not applicable". This indicates that a clinical study, which would typically involve human subjects and the kind of performance data (e.g., sensitivity, specificity) relevant to AI diagnostic devices, was not performed or deemed necessary for this type of medical device clearance.
Therefore, the requested information, which is more applicable to diagnostic AI devices, cannot be extracted from this document, as the Eclipse Blood Collection Set is a physical blood collection device and not an AI-powered diagnostic tool.
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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 DriveSuite 120The Colony, TX 75056 USA |
| Establishment Number: | 3009032449 |
| Contact Person: | Julie Summerville |
| Telephone:Email: | 972-380-2911jsummerville@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 SetThe reference device is included in this submission todemonstrate compliance to ISO 23908:2011 Sharps injuryprotection-Requirements and test methods. The sharpssafety protection for the Eclipse Blood Collection Set isidentical to the Safelock Disposable Blood Collection Set. |
| Regulatory Class: | Class II Prescription |
| Device Description: | The Eclipse Blood Collection Set is a winged blood collectionneedle with flexible tubing intended for venipuncture toobtain blood samples. It is provided with a safety shield forcovering the used venipuncture needle prior to disposal to aidin the prevention of needle stick injury if manually activated |
| after the blood draw. For blood collection, the set alsoincludes a blood collection holder for connection to vacuum-based collection vials | |
| Indications for Use: | The Eclipse Blood Collection Set with holder is intended to beused with vacuum blood collection tube for the collection ofvenous blood. The safety shield is intended to aid in theprotection against accidental needle stick injury. |
| Performance TestingSupport: | The following performance data was provided in support ofthe 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, <151> 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 BloodCollection Set | Predicate Device:Safety BloodCollection Needlewith/without Holder | Comparison | |
|---|---|---|---|
| 510(k) | K213690 | K200027 | N/A |
| Manufacturer | Eclipse MedCorp, LLCThe Colony, TX, U.S.A | Jiangsu Caina MedicalCo., 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 specimencollection device | Blood specimencollection device | Same |
| Indications for Use /Intended Use | The Eclipse BloodCollection Set withholder is intended to beused with vacuum bloodcollection tube for thecollection of venousblood. The safety shieldis intended to aid in theprotection againstaccidental needle stickinjury. | The Safety BloodCollection Needlewith/without Holder isintended to be used withvacuum blood collectiontube for the collection ofvenous blood. The safetyshield is intended to aidin the protection againstaccidental needle stickinjury.The Luer access device-holder with preattachedmultiple sample adapteris a sterile, non-invasivedevice used to connectdevices with male orfemale luer connectors toblood collection tubes forthe collection of blood | DifferentThe Eclipse BloodCollection set doesnot include thepreattached adaptertherefore this isexcluded from theindication for usefor the subjectdevice. |
| Subject Device:Eclipse BloodCollection Set | Predicate Device:Safety BloodCollection Needlewith/without Holder | Comparison | |
| Intended Users | Rx Only: Licensedhealthcarepractitioners orindividuals directed bypractitioners | Rx Only: Licensedhealthcarepractitioners orindividuals directed bypractitioners | Same |
| Needle Gauge forButterfly Needle | 23G | 20G - 23G | Different |
| Needle Length forthe Butterfly Needle | 19.5mm | 25.4mm31.75mm38.1mm | Different |
| Needle Gauge forTube Holder Needle | 21G | 18G-27G | Different |
| Needle Length forTube Holder Needle | 23.8mm with theexposed portion15mm | 23.8mm with theexposed portion 15mm | Same |
| Tube Holder volume | 22ml | 22ml | Same |
| Tube Holderfunction | Hold tube in placeduring blood draw | Hold tube in placeduring blood draw | Same |
| Adapter | Luer | Luer | Same |
| Needle Safety Shield | Protective sliding cap | Protective hinge shield | Different but sameas referencedevice |
| Configuration andMaterials | Protective Cover ofButterfly Needle –PolypropyleneRubber Sleeve – IsopreneRubber | Non-patient Needle Cap– PolypropyleneRubber Sleeve - CaseGather IsopreneRubber | Same |
| Patient Needle Tube –Stainless Steel | Patient Needle Tube –Stainless Steel | ||
| Tube Holder Needle –Stainless Steel | Needle Tube – StainlessSteel | ||
| Luer lock Male Hub –MABS | Luer Lock Male Hub –MABS | ||
| Tubing – PVC | Tubing – PVC | ||
| Safety Shield –Polypropylene | Safety Shield –Polypropylene | ||
| Subject Device:Eclipse BloodCollection Set | Predicate Device:Safety BloodCollection Needlewith/without Holder | Comparison | |
| *Tube Holder –Polypropylene | Tube Holder –Polypropylene | ||
| Lubricant -Polydimethylsiloxane | Lubricant -Polydimethylsiloxane | ||
| *NOTE: for the Eclipsedevice this is also calledthe Transfer Device | |||
| Sterilization Method | Ethylene Oxide (EtO)Gas Sterilization | Ethylene Oxide (EtO)Gas Sterilization | Same |
| Sterility | Meets the SAL of 10-6per ISO 11135-2014 | Meets the SAL of 10-6per 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 | <20 EU per device | <20 EU per device | Same |
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Discussion of Differences:
Needle gauge for the butterfly needle: The subject device is 23G which is a subset of the dimension for the predicate device, which is 20G – 23G. The subject device has only the 23G needle, but this size is previously cleared in the predicate device, therefore, it presents no new concerns for safety or efficacy. Therefore, the subject device needle gauge is the same as the predicate device. Performance testing was conducted per ISO 9626: 2016 Stainless Steel Needle tubing for the manufacture of medical devices and ISO 7864:2016 Sterile Hypodermic Needles for Single Use and verify the proposed device met all design specifications. There are no safety or efficacy concerns related to the use of the 23G needle.
Needle length for butterfly needle: The subject device length is 19.5mm. This is shorter than the lengths for the predicate device. According to peer reviewed published information butterfly needle length is typically between ½ to ¾ inches (12.7mm-19.05mm). This length is desirable because it can be inserted at a shallow angle and is therefore easier to use. The difference between 19.05mm (common size) and the subject device length of 19.50 is 0.45mm (0.017 inches) and is not significant Performance testing was conducted to the FDA consensus
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standards and verify the proposed device met all design specifications. The difference in length for the subject device and predicate device does not raise any new safety or efficacy concerns. Performance testing was conducted per ISO 9626: 2016 Stainless Steel Needle tubing for the manufacture of medical devices and ISO 7864:2016 Sterile Hypodermic Needles for Single Use and verify the proposed device met all design specifications. There are no safety or efficacy concerns related to the use of the 23G needle
Needle gauge for the needle within the tube holder: The 21G needle for the tube holder is a subset of the cleared sizes for the predicate device. The subject device is the same as the predicate device. Performance testing was conducted per ISO 9626: 2016 Stainless Steel Needle tubing for the manufacture of medical devices and ISO 7864:2016 Sterile Hypodermic Needles for Single Use and verify the proposed device met all design specifications. There are no safety or efficacy concerns related to the use of the 23G needle
Substantial Equivalence:
The Eclipse Blood Collection Set is substantially equivalent to the Jiangsu Caina Safety Blood Collection Needle with/without Holder predicate devices are under the same product code (JKA) and regulation number, both have the similar intended use/indication for use, similar lengths and gauges of needles, same materials, packaging and sterilization method. The only technological differences are the indications for use are with one exception. The Eclipse Blood Collection Set does not include a pre-attached adapter. Therefore, the following indication for use is not included: "The luer access device- holder with pre-attached multiple sample adapter is sterile, non-invasive device used to connect devices with male or female luer connectors to blood collection tubes for the collection of blood." The needle gauge is identical to the predicate, although both the butterfly needle within the tube holder differ in length between the proposed device and the predicate device; however, this difference is just in dimension. The difference in lengths is minor and does not raise new issues of safety or effectiveness and performance testing demonstrates the subject device can perform its intended function.
Conclusion:
The Eclipse Blood Collection Set is considered to be substantially equivalent to the predicate device based on the intended use, technological characteristics, and the results of device testing submitted.
§ 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.