(616 days)
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided text is a 510(k) summary for a medical device (Blood Collection Needles). This type of document focuses on demonstrating substantial equivalence to an already legally marketed predicate device, rather than proving efficacy or diagnostic performance through clinical trials as one might expect for an AI diagnostic device. Therefore, many of the typical questions for AI device studies (like those involving expert consensus, MRMC studies, or training set details) are not directly applicable or addressed in this document. The "tests" here are primarily engineering and safety validations against established standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (based on standards) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993-1 |
| Cytotoxicity | Conforms to ISO 10993-5:2009 |
| Irritation & Skin Sensitization | Conforms to ISO 10993-10:2010 |
| Systemic Toxicity | Conforms to ISO 10993-11:2006 |
| Material Mediated Pyrogenicity | Conforms to USP 41 <151> |
| Haemolytic Properties | Conforms to ASTM F756-08 |
| Interactions with Blood | Conforms to ISO 10993-4:2002/Amd 1:2006 |
| Particulate Matter | Conforms to USP <788> |
| Sterilization Validation | SAL 10-6 achieved |
| EO Sterilization Process | Conforms to ISO 11135:2014 |
| Biological Indicators | Conforms to ISO 11138-1:2017 |
| EO Sterilization Residuals | Conforms to ISO 10993-7:2008 |
| Packaging (Materials & Sterile Barrier) | Conforms to ISO 11607-1:2009 |
| Packaging (Validation Processes) | Conforms to ISO 11607-2:2006 |
| Microbiological Methods (Population) | Conforms to ISO 11737-1:2018 |
| Microbiological Methods (Sterility Tests) | Conforms to ISO 11737-2:2009 |
| Bacterial Endotoxins (LAL test) | Conforms to USP <85>, USP <161>, European Pharmacopoeia 2.6.14 |
| Performance Testing | |
| Sterile Hypodermic Needles (General) | Conforms to ISO 7864:2016 |
| Stainless Steel Needle Tubing | Conforms to ISO 9626:2016 |
| Sharps Injury Protection Features | Conforms to ISO 23908:2011 |
2. Sample size used for the test set and the data provenance
The document specifies non-clinical tests, primarily bench testing and laboratory analyses against international and FDA-recognized standards. It does not mention a "test set" in the context of patient data or images. Therefore, details like data provenance (country of origin, retrospective/prospective) and sample size in that sense are not applicable to this type of submission. The "samples" would be the manufactured devices themselves and their components, tested in laboratory conditions.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The "ground truth" for this device is based on established engineering and safety standards (e.g., ISO, ASTM, USP) for medical devices, rather than expert interpretation of clinical data or images. Compliance with these standards is demonstrated through laboratory testing conducted by qualified personnel within Vacutest Kima or accredited testing facilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This type of submission relies on objective measurements and conformance to standards, not human expert adjudication of clinical outcomes or diagnostic interpretations.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a medical device (blood collection needle), not an AI diagnostic tool. No MRMC study was conducted or is relevant for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this submission is established international and national standards for medical device safety and performance. This includes:
- Biocompatibility standards (e.g., ISO 10993 series, USP pyrogenicity, hemolytic properties)
- Sterilization validation standards (e.g., ISO 11135, ISO 11138, package integrity, endotoxin tests)
- Performance standards specific to hypodermic needles and sharps injury protection (e.g., ISO 7864, ISO 9626, ISO 23908)
The "proof" is the device's ability to consistently meet the specifications and requirements outlined in these standards through rigorous non-clinical testing.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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December 14, 2021
Vacutest Kima Srl Elisa Buggio Regulatory Assistant Via dell'Industria 12 Arzegrande, Padova 35020 Italy
Re: K200932
Trade/Device Name: Blood Collection Needles Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: FMI Dated: November 10, 2021 Received: November 15, 2021
Dear Elisa Buggio:
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
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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 (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 medical devices and radiation-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,
Gang Peng For Payal 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) K200932
Device Name Blood Collection Needles
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes.
The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
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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K200932 510(k) Summary
| Prepared Date: | December 8, 2021 |
|---|---|
| Applicant: | |
| Company Name: | Vacutest Kima s.r.l |
| Company Address: | Via dell'Industria 12 |
| 35020 Arzegrande (Padova) - Italy | |
| Company Phone: | +39 049 9719511 |
| Company Fax: | +39 049 9719542 |
| Company e-mail | info@vacutestkima.it |
| Official Contact for Correspondence: | Buggio Elisa |
| Phone: | +39 049 9719511 |
| E-mail: | regulatory@kima.it |
DEVICE IDENTIFICATION
| Trade name: | Blood Collection Needles |
|---|---|
| Generic/ Common Name: | Hypodermic needles |
| Classification: | 21 CFR §880.5570 |
| Class II | |
| Classification name: | Hypodermic single lumen needle |
| Product Code: | FMI |
| Panel: | General Hospital |
PREDICATE DEVICE:
BD Vacutainer® Eclipse™ Blood Collection Needle, BECTON DICKINSON VACUTAINER SYSTEMS
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DEVICE DESCRIPTION
The Vacutest Kima blood collection needles are sterile and disposable single use devices intended for the daily blood collection routine.
They are intended for single or multiple blood collection from one single patient, with vacuum blood collection tubes. The needles must be applied on a holder; a separate use is not possible.
The Safety Needle models feature a mechanism covering the needle after use; in these models a holder with pre-assembled safety cover is part of the device. The safety mechanism applied to the holder requires no change of the operative manners for blood collection.
| Gauge | Length |
|---|---|
| 18g, 20g, 21g, 22g | 1 ½ "& 1" |
| 20g, 21g, 22g (Needle safety feature) | 1 ½ "& 1" |
INDICATIONS FOR USE
The Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes. The Safety Blood Collection Needles are sterile, single use medical devices specifically intended to be used by trained healthcare professionals for the collection of blood samples into evacuated blood collection tubes; they are designed with a safety mechanism, which can be activated to cover the needle immediately after puncture to provide protection from accidental needle sticks.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Attribute /Characteristics | Blood Collection Needles(Submitted Product) | BD Vacutainer®Eclipse™ BloodCollection Needle,(Legally MarketedPredicate Device) | Comparison |
|---|---|---|---|
| 'K" numbers | K200932 | K982541 | |
| CFR Section | 880.5570 | 880.5570 | same |
| Pro-code | FMI | FMI | same |
| Classification name | Hypodermic single lumen needle | Hypodermic single lumen needle | same |
| Intended / Indications forUse | The Blood Collection Needles are sterile,single use medical devices specificallyintended to be used by trained healthcareprofessionals for the collection of bloodsamples into evacuated blood collectiontubes.The Safety Blood Collection Needles aresterile, single use medical devicesspecifically intended to be used by trainedhealthcare professionals for the collectionof blood samples into evacuated bloodcollection tubes; they are designed with asafety mechanism, which can be activatedto cover the needle immediately afterpuncture to provide protection fromaccidental needle sticks. | The BD Vacutainer® Eclipse™Blood Collection Needle is asterile, multiple sample, single-use device for blood collection.The needle is designed with anattached safety shield, whichcan be activated to cover theneedle immediately aftervenipuncture to provideprotection from accidentalneedle sticks. | Comment #1Different: both the subjectand the predicatedevice areindicated for use in clinicalenvironments forbloodcollection; the subject deviceis also offered withoutsafetymechanism, but this doesnot impact the device'sdiagnostic/ therapeutic useor raise new questions ofsafety or effectiveness ascompared to the predicate |
| Cannula material | AISI 304 Stainless Steel | AISI 304 Stainless Steel | same |
| Attribute /Characteristics | Blood Collection Needles(Submitted Product) | BD Vacutainer®Eclipse™ BloodCollection Needle,(Legally MarketedPredicate Device) | Comparison |
| Hub material | Polypropylene (PP) | Polystyrene (PS) | Different: both polymers; PPis commonly used toManufacture plasticlaboratory supplies |
| Hub color | color coded ISO 6009 | color coded ISO 6009 | same |
| Rubber sleeve | synthetic Isoprene | synthetic Isoprene | same |
| Cover | rigid cover, polypropylene | rigid cover, polyethylene | same |
| Adhesive | epoxy type adhesive | epoxy type adhesive | same |
| Lubricant | medical grade silicone oils | medical grade silicone oils | same |
| Needle diameter (gauge) | 18G, 20G, 21 G, 22G | 21 G, 22G | Comment #2Different: The submitteddevice is offered in a widerrange of needle options incomparison to the predicatedevice; this does not affectthe operation of the device,as proved by thenon-clinicaltests performedon the subject device. |
| Needle length | 1 inch, 1 ½ inch | 1 ¼ inch | Comment #2Different: The differences inthe needle length betweenthe subject and the primarypredicate device do notimpact the subject deviceperformances; there are nopotential issues of safety andeffectiveness for thesedifferences in the length of theneedle, as proved by the non-clinical tests performed onthe subjectdevice |
| Tip configuration | double tipped: the longest portion of theneedle is used to puncture the patient'svein, the shortest part fits inside the tubeholder | double tipped: the longestportion of the needle is used topuncture the patient's vein, theshortest part fits inside thetube holder | same |
| Shelf life | 3 years | 5 years | Different: The shorter shelflife of the subject deviceposes no new issues ofsafety and effectiveness incomparison to the longershelf life of thepredicate device |
| Attribute /Characteristics | Blood Collection Needles(Submitted Product) | BD Vacutainer®Eclipse™ BloodCollection Needle,(Legally MarketedPredicate Device) | Comparison |
| Primary Packaging | individually packed with a plastic covercomposed by 2 parts sealed with a label orpacked in sealed individual blisters | individually sealed sterilepouch | Different: Both the packagingsystems used for the subjectdevices are validated and theSAL is 10-6 substantiallyequivalent |
| Secondary Packaging | cardboard box | cardboard box | same |
| Sterilization | Ethylene Oxide (EO)SAL 10-6 | Gamma irradiationSAL 10-6 | Comment #3Different: A differentsterilizationmethod is appliedon the subject device incomparison with thepredicate device, buttheassurance sterility level is thesame. Thus, no issues ofsafety arise. |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | same |
| Functional testing | Testing in compliance withISO 7864:2016ISO 9626:2016ISO 23908:2011 | ISO 7864:1993ISO 9626:1991 | Different: the subject devicecontains testing for the safetyfeature |
| Sharps injurypreventionfeature | Blood Collection Needles(Submitted Product) | BD Vacutainer®Eclipse™ BloodCollection Needle(Legally MarketedPredicate Device) | Comparison |
| Material | Plastic (PP) | Plastic (PP) | same |
| Pigments | Transparent Light blue | Transparent pink | Different: Both mechanismsare made with transparentplastic that allows theoperator to see the correctclosure of the safetydevice |
| Bonding agents | None | None | same |
| Technical description | The safety shield is connected to theholder. The safety needle cover ispositioned so as not to interfere withblood collection; it can be rotated tofind a suitable position during theblood collection.Activation can be done by the userwith a single-handed technique.Once activated, the safety devicecompletely encloses the needle andcannot be disengaged. | The safety shield is connected tothe needle, in a fixed positionthus it can't be rotated.Activation can be done by theuser with a single-handedtechnique.Once activated, the shieldcompletely enclose the needle,mechanism cannot bedisengaged. | Different:In the predicate device thesafety shield is connected tothe needle, in a fixed position,while in the subject device itis connected to the holderand it can rotate. Thisdifference in the design of thesubject device facilitates theblood collection and does notaffect the safety andeffectiveness of the subject |
| Length: 53.5 | Length 47.70Distance from the holder: 11 mm | device, as proved by thebenching tests performed. | |
| Principle ofoperation | Rotate the light blue safety needlecover towards the bottom of holder.Remove the transparent needle cover.Perform blood collection according tosafety procedures. Immediately afterthe blood collection, activate the safetydevice with a thumb. The safety deviceis close to holder so that the single handtechnique activation could be donesimply sliding the thumb along the wallof the holder. Closing operation endsafter hearing a click and with the visualcheck of locking of needle. | Gently position pink safety shieldstraight back toward the holder.Twist and pull colored needle capstraight off. Holding the barrel ofthe holder, perform venipunctureper your facility's procedure.Immediatelyafter removingneedle from vein, position thumbsquarely on pink safety shieldthumb pad and push pink safetyshield forward to cover needle.An audible click may be heard.Lock shield into place and inspect.Do not attempt to engage safetyshield by pressing against a hardsurface. | Different:Both devices can be activatedwith a single hand techniqueand cannot be disengaged.Both devices are in a positionso as not to interfere withblood collection. In thesubmitted product the safetydevice can be rotated to finda suitable position to performthe venipuncture. |
| Activation Method | Activate the safety device with a thumbsimply sliding the thumb along the wallof the holder. Closing operation endsafter hearing a click and with the visualcheck of locking of needle. | Position thumb squarely on pinksafety shield thumb pad and pushpink safety shield forward tocover needle. An audible clickmay be heard. Lock shield intoplace and inspect. | Different:The safety mechanism isactivated in both the devicesby pushing it with the thumb.The activation method of thesubmitted device allows theoperator to close the safetydevice keeping the holder inthe same position during allblood collection procedure. |
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Predicate Device Comparison Chart - sharps injury prevention feature
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SUBSTANTIAL EQUIVALENCE DISCUSSION:
Comment #1
The Blood Collection Needles are same or similar in intended use, materials and design to the predicate device (K982541). Both the subject and the predicate device are in clinical environments for blood collection. Both the devices have the same principle of operation, same overall design, including use of a holder; the same method of use and very limited duration of contact (≤ 3 min.) with patient's blood; the same cannula material, similar geometry and gauge.
Both the subject and the predicate device are provided with or without a preassembled holder.
The subject device is also offered without safety mechanism, but this does not impact the device's diagnostic/therapeutic use or raise new questions of safety or effectiveness as compared to the predicate. As for the safety mechanism, the subject device is substantially equivalent to the predicate device in materials, design and principle of operation of the sharps injury prevention feature; the slight differences do not affect the safety and effectiveness of the safety shield of the subject device, as proved by the benching tests performed.
Comment #2
The subject device is available in sizes 18g-22g inch x 1 ½ & 1 inch lengths, the predicate device is available in sizes 21g-22g x 1 ¼ inch. Venous flow through the inner diameter of the cannula into attached blood collection tubes is the technological principle for both the subject and predicate device. The subject and predicate device are based on the same or similar technological elements and are made with the same materials, largely used for the same type of medical devices already on the market.
The minor differences in gauge and length of the devices do not impact the safety and effectiveness of the subject device. The performance data (design verification testing) demonstrate that the subject device is as safe and effective as the cited predicates. Thus, the Blood Collection Needles are substantially equivalent to the proposed predicate device.
Comment #3
There are minor differences in sterilization method and shelf life. Sterilization validation, shelf-life and package integrity testing demonstrate that the subject device maintains its sterility and performance through its expiration. These differences do not raise any new types of safety or effectiveness questions.
DISCUSSION OF NON-CLINICAL TESTS
Biocompatibility
In accordance with ISO 10993-1, the Blood Collection Needle is classified as Externally Communicating Device, Blood Path Direct, Limited Contact (<24 hours). The following testing was conducted:
- . ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 10993-11:2006, Biological evaluation of medical devices — Part 11: Tests for systemic
- USP 41 <151>, Material Mediated pyrogenicity
- . ASTM F756-08, "Standard Practice for Assessment of Haemolytic Properties of Materials
- ISO 10993-4:2002/Amd 1:2006: "Biological evaluation of medical devices Part 4: Selection of tests ● for interactions with blood
- . USP<788>, Particulate matter in injections
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Sterilization Validation
The sterile Blood Collection Needle described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 11135:2014, Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices,
- ISO 11138-1: 2017, Sterilization of health care products -- Biological indicators Part 1: General ● requirements.
- ISO 10993-7 :2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals.
- . ISO 11607-1:2009. Packaging for terminally sterilized medical devices-Part 1: Requirements for materials, sterile barrier systems and packaging systems
- . ISO 11607-2:2006. Packaging for terminally sterilized medical devices-Part 2: Validation requirements for forming, sealing and assembly processes
- . ISO 11737-1:2018, Sterilization of health care products-Microbiological methods-Part1: Determination of a population of microorganisms on products.
- . ISO 11737-2:2009, Sterilization of medical devices-Microbiological methods-Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- . LAL test was performed according to:
- USP 39th ed. 2016: <85> Bacterial Endotoxins Test
- USP 39th ed. 2016: <161> Transfusion and infusion assemblies and similar medical devices.
- European Pharmacopoeia current edition: 2.6.14 Bacterial Endotoxins.
Performance Testing
The sterile, Blood Collection Needles described in this summary were tested and demonstrated to be in conformance with the following FDA recognized standards:
- ISO 7864:2016, "Requirements and test methods Sterile hypodermic needles for single use. Requirements and test methods",
- ISO 9626:2016, "Stainless steel needle tubing for the manufacture of medical devices. Requirements and test methods"
- . ISO 23908:2011, "Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
CONCLUSION:
The differences between the predicate device and the subject device do not raise any new or different questions of safety or effectiveness. The Blood Collection Needle is substantially equivalent to the BD Vacutainer Blood Collection Needle.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).