(169 days)
No
The device description and performance studies focus on the mechanical function and physical properties of a blood collection tube holder, with no mention of AI or ML technologies.
No
The device is used for the collection of blood specimens, not for treating or diagnosing a medical condition.
No
The device description clearly states its purpose is for the "collection of blood specimens" and it is a "tube holder". There is no mention of analysis, diagnosis, or interpretation of medical conditions.
No
The device description clearly describes a physical, single-use plastic holder with specific features for connecting to needles and blood collection tubes, indicating it is a hardware device.
Based on the provided text, the Bevel Up Holder is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the collection of blood specimens during routine venipuncture. It facilitates the physical process of drawing blood into tubes.
- Device Description: The description focuses on the physical components and how it connects to needles and tubes for blood collection.
- Lack of Diagnostic Function: There is no mention of the device being used to perform any test or analysis on the collected blood specimen. It is purely a tool for the collection process itself.
- Performance Studies: The performance studies focus on the physical functionality of the device (fit, leakage, function, deformation, force, connectivity, shelf life, biocompatibility), not on the accuracy or reliability of any diagnostic result.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Bevel Up Holder's function is limited to the pre-analytical step of specimen collection.
N/A
Intended Use / Indications for Use
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.
Product codes
JKA
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.
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
trained healthcare professional / 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
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.
Additional performance testing was carried out:
- Deformation Test: Device held in place with fixture, 5 kg force applied for 5 minutes. No permanent change in outer diameter detected.
- Insertion and Evacuation Force Test: Force to insert/evacuate blood collection tube recorded. Device met defined acceptance criteria.
- Connectivity Test: Device connected to interface devices (Becton Dickinson Eclipse Needle Set, Becton Dickinson Vacutainer Multi Sample, Becton Dickinson Safety Lok Blood Collection Set). Simulated blood collection showed no leakage with good fit and function.
- Shelf Life: Accelerated Aging Test (ASTM F1980-2007) conducted. Device functioning well, meeting defined shelf life.
- Bio Compatibility: Leveraged from testing on Blood Transfer Accessory (K181743) as the device is identical in formulation, processing, and geometry. Deemed to have met biocompatibility requirements for Cytotoxicity, Sensitization and Irritation Reactivity.
Key Metrics
All Bevel Up Holders met the acceptance criteria for fit, leakage and function when used for blood collection.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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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)
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.
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 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.
V. INDICATIONS FOR USE STATEMENT
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.
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 Ltd
Bevel Up Holder (BUH) | Greiner Bio One
VACUETTE® Blood Culture Holder |
|----------------|-------------------------------------------|---------------------------------------------------|
| 510(k) Number | K193074 | K122687 |
| Classification | Class II | Class II |
| Product Code | JKA | JKA |
| Device Name | NSP Tech Pte Ltd
Bevel Up Holder
(BUH) | Greiner Bio One
VACUETTE® Blood
Culture Holder | Comparison |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
For Use | The Bevel Up
Holder is used for
the collection of
blood into 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. | The Blood Culture
Holder is used to fill
blood into blood
culture bottles and
tubes in routine
venipuncture
procedures. This
device is to be used
by properly trained
healthcare
professionals only
in accordance with
these instructions. | Both the Bevel
Up Holder and
the predicate
device are used
for collection of
blood into
collection tubes
carried out in
routine
venipuncture
procedures by
trained
healthcare
professional.
Hence, they are
similar in the
Indication For
Use. |
| Manufacturer | NSP Tech Pte Ltd | Greiner Bio One | N/A |
| Product
Configuration | Clear plastic
Holder | Clear plastic Holder | Same |
| Material | Polypropylene | Polypropylene | Same |
| Sterility | Not sterilized | Not sterilized | Same |
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| Packaging | Bulk pack in poly
bag | Bulk pack in poly
bag. | Same |
|----------------------|---------------------------------------------------------------------------|---------------------------|-----------|
| Use | Single-Use Only | Single-Use Only | Same |
| Bio
Compatibility | Leveraged from
Blood Transfer
Accessory
(K181743)10993
series | 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.