Bevel Up Holder by NSP Tech Pte Ltd

The Bevel Up Holder is used for the collection of blood collection tubes in routine venipuncture procedures. It is used with blood collection sets, needles and tubes. The device is to be used by trained healthcare professional only.

Device Description

The Bevel Up Holder device is a single use and non-invasive device to be used in venipuncture procedures for the collection of blood specimens. It is to be used as a Tube Holder with blood collection tubes such as the Becton Dickinson Vacutainer® blood collection tube. The Bevel Up Holder device is also used with blood collection needles and blood collection sets such as the Becton Dickinson Eclipse Needle set, Becton Dickinson Vacutainer Multi Sample and Becton Dickinson Safety Lok Blood Collection Set for the collection of blood specimen into the blood collection tubes. The Bevel Up Holder is to be used by trained healthcare professional only and is intended for prescription use.

The Bevel Up Holder has a clear plastic holder body with an opening on one end for the insertion of blood collection tube and an interface device connecting feature on the other end for venous access device for connecting to blood collection needle and blood collection set.

The connecting end of the venous access device of the Bevel Up Holder (BUH) device allows the adjusting of the position of the venous access device with rotating it.

AI/ML Overview

The provided document, a 510(k) premarket notification for the "Bevel Up Holder," details various tests and their outcomes. However, it does not delineate specific numerical acceptance criteria for each test nor present the reported performance values in a direct comparative table as requested. Instead, it generally states that the device "met the acceptance criteria" or "shows no permanent change."

Here's an attempt to answer the questions based on the available information:

1. A table of acceptance criteria and the reported device performance

Test	Acceptance Criteria (not explicitly quantified in the document)	Reported Device Performance
Simulated Blood Collection	Proper fit, no leakage, and proper function when used for blood collection.	"All Bevel Up Holders met the acceptance criteria for fit, leakage and function when used for blood collection."
ASTM D4169-16 (Performance Testing of Shipping Containers and Systems)	Implied to withstand shipping conditions without degradation.	"The device meets the functional and performance requirements, underwent testing in accordance with..."
ISO 14971:2007 (Application of Risk Management to Medical Devices)	Implied to have acceptable risk levels.	"The device meets the functional and performance requirements, underwent testing in accordance with..."
ASTM F88/F883-15 (Seal Strength of Flexible Barrier Materials)	Implied to have adequate seal strength.	"The device meets the functional and performance requirements, underwent testing in accordance with..."
Deformation Test	No permanent change in outer diameter after applying 5 kg force for 5 minutes.	"Result of the test shows no permanent change in the outer diameter of the Bevel Up Holder (BUH)."
Insertion and Evacuation Force Test	Meeting defined acceptance criteria for the force required to insert/evacuate a blood collection tube.	"Result shows the device meeting the defined acceptance criteria in the insertion and evacuation of the blood collection tube into the Bevel Up Holder (BUH) for blood collection operation."
Connectivity Test	No leakage with good fit and function when connected to specified interface devices during simulated blood collection.	"Result shows no leakage with good fit and function for the connectivity of the Bevel Up Holder (BUH) to the interface devices."
Shelf Life (Accelerated Aging Test per ASTM F1980-2007)	Device still functioning well after simulating the defined years of shelf life (3 years).	"Result shows that the Bevel Up Holder (BUH) meeting the defined shelf life with device still functioning well."
Biocompatibility (Cytotoxicity, Sensitization, Irritation Reactivity)	Meet biocompatibility requirements.	"The Bevel Up Holder (BUH) is deemed to have met the biocompatibility requirements for Cytotoxicity, Sensitization and Irritation Reactivity."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: For the simulated blood collection test, 20 sets of the subject device (Bevel Up Holder) and interface device were used. For the deformation test, the sample size is not explicitly stated but implies testing of "the device." The same applies to the insertion and evacuation force test, connectivity test, and shelf life test. Biocompatibility was leveraged from another device.
Data Provenance: The document does not specify the country of origin where the tests were conducted or if the data was retrospective or prospective. Given the applicant is from Singapore, it's plausible the testing occurred there, but this is not confirmed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the device is a blood specimen collection tube holder, not an AI or diagnostic device that requires expert ground truth establishment in the traditional medical imaging sense. The testing focuses on physical and functional performance, not diagnostic accuracy.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as above. No diagnostic interpretations or clinical assessments requiring adjudication were performed.

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

This is not applicable. The device is a physical medical instrument, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical instrument, not an algorithm. Performance tests evaluate the device's physical and functional properties.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The concept of "ground truth" as typically used for AI or diagnostic devices does not directly apply to this product. The "truth" for this device's performance is established by:

Physical measurements (e.g., outer diameter in the deformation test, force in insertion/evacuation test).
Visual inspection (e.g., fit, leakage, function in simulated blood collection and connectivity tests).
Standardized test methods (e.g., ASTM, ISO standards).
Leveraging prior biocompatibility data for a similar device.

8. The sample size for the training set

This is not applicable as the device is a physical product and does not involve AI or machine learning that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable for the reasons stated above.

Summary

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April 21, 2020

NSP Tech Pte Ltd HC Tan Operations Manager 10 Admiralty Street, Northlink Building, #02-06 757695 SINGAPORE

Re: K193074

Trade/Device Name: Bevel Up Holder Regulation Number: 21 CFR 862.1675 Regulation Name: Blood Specimen Collection Device Regulatory Class: Class II Product Code: JKA Dated: March 2, 2020 Received: March 4, 2020

Dear HC Tan:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 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.

for Tina Kiang Ph.D. 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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193074

Device Name

BEVEL UP HOLDER

Indications for Use (Describe)

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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l. SUBMITTER:

Applicant Name:

NSP Tech Pte Ltd 10 Admiralty Street, Northlink Building #02-06, Singapore 757695

Phone: (65) 67478177

Contact Person:

Name: HC Tan Phone: (65) 98180450 Fax: (65) 67476533 Email: hockchoon.tan@nsptech.com.sg

Date Prepared:

20th February 2020

II. DEVICE

Name	:	Bevel Up Holder
Trade Name	:	BUH
Common Name	:	Blood Collection Tube Holder
Classification Name	:	Blood Specimen Collection Device
Regulatory code	:	21 CFR 862.1675
Regulatory Class	:	Class II
Product Code	:	JKA

lll. PREDICATE DEVICE:

Trade Name	:	VACUETTE Blood Culture Holder
510(K) Number	:	K122687
Common Name	:	Blood Collection Tube Holder

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Classification Name	Blood Specimen Collection Device
Regulatory code	21 CFR 862.1675
Regulatory Class	Class II
Product Code	JKA

DEVICE DESCRIPTION IV.

The connecting end of the venous access device of the Bevel Up Holder (BUH) device allows the adjusting of the position of the venous access device with rotating it.

V. INDICATIONS FOR USE STATEMENT

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VI. PREDICATE DEVICE

Information was submitted to demonstrate that there are no significant differences in technological characteristics between the Bevel Up Holder (BUH) and the predicate device.

The following comparison chart shows that the subject device and the predicate device are substantially equivalent:

TABLE OF COMPARISON BETWEEN SUBJECT DEVICE AND PREDICATE DEVICE

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Device Name	NSP Tech Pte LtdBevel Up Holder (BUH)	Greiner Bio OneVACUETTE® Blood Culture Holder
510(k) Number	K193074	K122687
Classification	Class II	Class II
Product Code	JKA	JKA

Device Name	NSP Tech Pte LtdBevel Up Holder(BUH)	Greiner Bio OneVACUETTE® BloodCulture Holder	Comparison
IndicationsFor Use	The Bevel UpHolder is used forthe collection ofblood into bloodcollection tubes inroutinevenipunctureprocedures. It isused with bloodcollection sets,needles andtubes. The deviceis to be used bytrained healthcareprofessional only.	The Blood CultureHolder is used to fillblood into bloodculture bottles andtubes in routinevenipunctureprocedures. Thisdevice is to be usedby properly trainedhealthcareprofessionals onlyin accordance withthese instructions.	Both the BevelUp Holder andthe predicatedevice are usedfor collection ofblood intocollection tubescarried out inroutinevenipunctureprocedures bytrainedhealthcareprofessional.Hence, they aresimilar in theIndication ForUse.
Manufacturer	NSP Tech Pte Ltd	Greiner Bio One	N/A
ProductConfiguration	Clear plasticHolder	Clear plastic Holder	Same
Material	Polypropylene	Polypropylene	Same
Sterility	Not sterilized	Not sterilized	Same

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Packaging	Bulk pack in polybag	Bulk pack in polybag.	Same
Use	Single-Use Only	Single-Use Only	Same
BioCompatibility	Leveraged fromBlood TransferAccessory(K181743)10993series	ISO 10993 series	Same Same
Shelf Life	3 years	3 years	Same

Similarities:

The Bevel Up Holder device has similarities with the predicate device in areas such as Indications For Use, Product configuration, Material used, Principle of operations of safety feature and technological characteristics. The safety and effectiveness of the two devices are similar.

Differences:

The Bevel Up Holder device differs from the predicate device in the design where the latter has a bluish appearance for the color of the device.

PERFORMANCE DATA VII.

Simulated blood collection was performed on the Bevel Up Holder using the respective interface devices each time which is the

. Becton Dickinson Eclipse Needle Set
. Becton Dickinson Vacutainer Multi Sample
. Becton Dickinson Safety Lok Blood Collection Set

For each of the above interface device, the test involves using a new Bevel Up Holder connected to a new set of interface device each time and the blood collection process carried out. This is done with 20 sets of the subject device and interface device. The results were evaluated for proper fit, leakage and function of the devices. All Bevel Up Holders met the acceptance criteria for fit, leakage and function when used for blood collection. The device meets the functional and performance requirements, underwent testing in accordance with the following recognized consensus standards:

ASTM D4169-16: Standard practice for performance testing of shipping . containers and systems.
ISO 14971;2007: Medical Devices-Application of Risk management of medical ● devices
ASTM F88/F883-15: Standard test method for seal strength of flexible barrier . materials

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In addition, the following performance testing was carried out on the Bevel Up Holder.

· Deformation Test

The device was tested by holding it in place with a fixture and a 5 kg force is applied on the device for a period of 5 minutes. Any permanent change in outer diameter of the device before and after compression by the applied force is measured and recorded. This test assesses the quality of the device. Result of the test shows no permanent change in the outer diameter of the Bevel Up Holder (BUH).

• Insertion and Evacuation Force Test

The device is held in place by a fixture and the force taken to insert or evacuate a blood collection tube into the device is recorded and result shows the device meeting the defined acceptance criteria in the insertion and evacuation of the blood collection tube into the Bevel Up Holder (BUH) for blood collection operation.

• Connectivity Test

The device was tested for connectivity by connecting them to the interface devices such as Becton Dickinson Eclipse Needle Set, Becton Dickinson Vacutainer Multi Sample and Becton Dickinson Safety Lok Blood Collection Set for the test with each of the respective devices. The blood collection operation is then simulated and result shows no leakage with good fit and function for the connectivity of the Bevel Up Holder (BUH) to the interface devices.

· Test: Shelf Life

An Accelerated Aging Test is done with reference to ASTM F1980-2007 is conducted for the device to simulate the defined years of shelf life. Result shows that the Bevel Up Holder (BUH) meeting the defined shelf life with device still functioning well.

· Bio Compatibility

The Bevel Up Holder device in its finished form is identical to Blood Transfer Accessory (K181743) in formulation (material), processing, and geometry and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).Leveraging on the bio compatibility result of this similar identical device, the Bevel Up Holder (BUH) is deemed to have met the biocompatibility requirements for Cytotoxicity, Sensitization and Irritation Reactivity.

· Sterilization

The device is not required to be sterilized.

SUBSTANTIAL EQUIVALENCE CONCLUSION VIII.

The result of the non-clinical testing demonstrates that the Bevel Up Holder (BUH) is substantially equivalent to the predicate device. VACUETTE® Blood Culture Holder.

Hence, we conclude that based on the information above, the Bevel Up Holder (BUH) is substantially equivalent to the predicate device, VACUETTE® Blood Culture Holder.

Regulation Number and Section

§ 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.