(267 days)
Not Found
No
The device description and intended use are purely mechanical, describing a syringe for a manual technique (Loss of Resistance). There is no mention of any computational or analytical capabilities that would involve AI/ML.
No
The device is described as a syringe used to verify needle tip placement by the loss of resistance technique and is explicitly stated as "not intended for injection or aspiration," indicating it does not deliver or remove substances for therapeutic effect.
Yes
Explanation: The device is used to "verify the needle tip placement in the epidural space by the loss of Resistance technique," which is a diagnostic function to determine the needle's location.
No
The device description clearly states it is a physical syringe made of plastic with a barrel, plunger, and piston, and details physical testing performed.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to verify needle tip placement in the epidural space using the loss of resistance technique. This is a procedural aid used during a medical procedure on a patient's body.
- Mechanism: The device works by detecting a change in resistance when the needle enters the epidural space, which is a physical phenomenon. It does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
- Lack of Biological Sample Analysis: The description explicitly states it will be filled with air and/or saline, not biological samples.
- No Mention of Diagnostic Information: The device's function is to confirm a physical location, not to diagnose a disease or condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that definition.
N/A
Intended Use / Indications for Use
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
Product codes
CAZ
Device Description
The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml).
The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epidural space
Indicated Patient Age Range
adults
Intended User / Care Setting
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The testing included the following items :
Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.
Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
Connector Compatibility Test: In order to prove that the connector of the proposed device will not have the risk of incorrect connection with the connector of other incompatible device, connector compatibility test was carried out, which proved that the proposed device would not be connected with incompatible connector.
Biocompatibility testing: The contact level of the proposed device is indirect contact duration is limited contact (
§ 868.5140 Anesthesia conduction kit.
(a)
Identification. An anesthesia conduction kit is a device used to administer to a patient conduction, regional, or local anesthesia. The device may contain syringes, needles, and drugs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 12, 2021
Jiangsu Caina Medical Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, 200120 China
Re: K201356
Trade/Device Name: Plastic LOR Syringe Regulation Number: 21 CFR 868.5140 Regulation Name: Anesthesia conduction kit Regulatory Class: Class II Product Code: CAZ Dated: January 12, 2021 Received: January 13, 2021
Dear Diana Hong:
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
1
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 (OS) 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 Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201356
Device Name Plastic LOR Syringe
Indications for Use (Describe)
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subnart C) |
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The as signed 510(k) Number: _K201356
-
- Date of Preparation: 2/10/2021
-
- Sponsor Identification
Jiangsu Caina Medical Co., Ltd. No.23, Huanxi Road, Zhutang Town, Jiangyin City, Jiangsu, 214415, China
Establishment Registration Number: 3005670221
Contact Person: Jianwei Pan Position: Management Representative Tel: +86-510-8686 6666-8027 Fax: +86-510-8686 6666-8009 Email:jianwei.pan @cainamed.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Plastic LOR Syringe Common Name: Loss of Resistance Syringe Models: 5 ml Luer lock, 5ml Luer slip, 5ml NRfit lock, 5ml NRfit Slip; 7 ml Luer lock, 7ml Luer slip, 7ml NRfit lock, 7ml NRfit Slip; 10 ml Luer lock, 10ml Luer slip, 10ml NRfit lock, 10ml NRfit Slip; 20 ml Luer lock, 20ml Luer slip, 20ml NRfit lock, 20ml NRfit Slip;
Regulatory Information
Classification Name: Anesthesia conduction kit; Classification: II; Product Code: CAZ; Regulation Number: 21CFR 868.5140; Review Panel: Anesthesiology;
Indication for Use:
The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.
Device Description
The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml).
The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years. The intended patient population is adults.
- ર. Identification of Predicate Device
Predicate device 1 510(k) Number: K061737
5
Product Name: BusseLoss of Resistance Syringe
Predicate device 2 510(k) Number: K190345 Product Name: VPC
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to the predicate device. The testing included the following items :
Physical, Mechanical, Chemical testing listed in following table were performed on the proposed device. The test results show that the device conforms with the requirements of related standards.
| General requirements | Clause 5 of ISO 7886-1:2017 |
|---|---|
| Extraneous matter | Clause 6 of ISO 7886-1:2017 |
| Lubricant | Clause 7 of ISO 7886-1:2017 |
| Tolerance on graduated capacity | Clause 8 of ISO 7886-1:2017 |
| Graduated scale | Clause 9 of ISO 7886-1:2017 |
| Barrel | Clause 10 of ISO 7886-1:2017 |
| Piston stopper/ plunger assembly | Clause 11 of ISO 7886-1:2017 |
| Nozzle | Clause 12 of ISO 7886-1:2017 |
| Performance | Clause 13 of ISO 7886-1:2017 |
| Dimensional requirements for | |
| neuraxial SMALL-BORE | |
| CONNECTOR | Clause 5 of ISO 80369-6:2016 |
| Fluid leakage | Clause 6.1 of ISO 80369-6:2016 |
| Sub-atmospheric pressure air | |
| leakage | Clause 6.2 of ISO 80369-6:2016 |
| Stress cracking | Clause 6.3 of ISO 80369-6:2016 |
| Resistance to speration form axial | |
| load | Clause 6.4 of ISO 80369-6:2016 |
| Resistance to separation from | |
| unscrewing | Clause 6.5 of ISO 80369-6:2016 |
| Resistance to overiding | Clause 6.6 of ISO 80369-6:2016 |
| Dimensional requirements for | |
| LUER CONNECTOR | Clause 5 of ISO 80369-7:2016 |
| Fluid leakage | Clause 6.1 of ISO 80369-7:2016 |
6
| Sub-atmospheric pressure air leakage | Clause 6.2 of ISO 80369-7:2016 |
|---|---|
| Stress cracking | Clause 6.3 of ISO 80369-7:2016 |
| Resistance to speration form axial load | Clause 6.4 of ISO 80369-7:2016 |
| Resistance to separation from unscrewing | Clause 6.5 of ISO 80369-7:2016 |
| Resistance to overiding | Clause 6.6 of ISO 80369-7:2016 |
Sterile barrier packaging testing were performed on the proposed device, which include visual inspection (ASTM F1886/F1886M-16), seal strength (ASTM F88/F88-15) and dye penetration test (ASTM F1929-15). The test result showed that the device package can maintain its integrity.
Sterilization and shelf life testing listed in following table were performed on the proposed device. EO ECH residue did not exceed the limit of ISO 10993-7. Endotoxin limit did not exceed 20EU/device. Shelf life test result showed that the device can maintain its performance during the claimed shelf life.
| EO residue | ISO 10993-7:2008 |
|---|---|
| ECH residue | ISO 10993-7:2008 |
| Bacteria Endotoxin Limit | USP 39-NF 34 |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package Tests |
| were performed on aging samples to verify the | |
| claimed shelf life of the device |
Connector Compatibility Test
In order to prove that the connector of the proposed device will not have the risk of incorrect connection with the connector of other incompatible device, connector compatibility test was carried out, which proved that the proposed device would not be connected with incompatible connector.
Biocompatibility testing
The contact level of the proposed device is indirect contact duration is limited contact ( Cytotoxicity,
-
Sensitization,
- A Intracutaneous reactivity,
7
- ) Acute Systemic Toxicity,
- ) Pyrogen
-
Particulate testing
-
- Clinical Test Conclusion
No clinical study is included in this submission.
8
8. Substantially Equivalent (SE) Comparis on
| Table 1 Substantially Equivalent Comparison | |
|---|---|
| --------------------------------------------- | -- |
| ITEM | Proposed Device | Predicate Device 1
K061737 | Predicate Device 2
K190345 | Remark | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|---------------|
| Product | Plastic LOR Syringe | Busse Loss of
Resistance Syringe | VPC | / | |
| Product Code | CAZ | CAZ | CAZ | SE | |
| Regulation
Number | 21 CRF 880.5140 | 21 CRF 880.5140 | 21 CRF 880.5140 | SE | |
| Class | Class II | Class II | Class II | SE | |
| Indication for
Use | The Plastic LOR
Syringe is intended
for use in
conjunction with an
epidural needle, to
verify the needle tip
placement in the
epidural space by the
loss of Resistance
technique, it will be
filled with air and/or
saline during use.
The loss of
Resistance Syringe is
not intended for
injection or
aspiration. The
syringe will be sold
sterile individually
packaged, and as part
of a sterile kit. | The Busse Loss of
Resistance Syringe is
intended for use in
conjunction with an
epidural needle, to
verify the needle tip
placement in the
epidural space by the
loss of Resistance
technique, it will be
filled with air and/or
saline during use.
The loss of
Resistance Syringe is
not intended for
injection or
aspiration. The
syringe will be sold
sterile individually
packaged, and as part
of a sterile kit. | The VPC (Visual
Pressure Control)
NRFitTM
(ISO80369-6) and
LUER (ISO80369-7)
Loss of Resistance
Syringe is intended
for use in
conjunction with an
epidural needle, to
verify the needle tip
placement in the
epidural space by the
loss of Resistance
technique, it will be
filled with air and/or
saline during use.
The loss of
Resistance Syringe is
not intended for
injection or
aspiration. The
Syringe will be sold
sterile individually
packaged, and as
part of a sterile kit. | Analysis
1 | |
| Configuration | Barrel (luer lock, luer
slip, NRFit lock,
NRFit slip) | Barrel (luer lock/luer
slip) | Barrel (luer lock,
NRFit lock) | Analysis
2 | |
| | | Plunger | Plunger | Plunger | SE |
| | | Piston | Piston | Piston | SE |
| Operation Mode | | For manual use only | For manual use only | For manual use only | SE |
| Product states | | Sterile product;
Non-sterile product | Sterile product; | Sterile product;
Non-sterile product | Analysis
1 |
| Single Use | | Single Use | Single Use | Single Use | SE |
| Label/Labeling | | Complied with 21
CFR part 801 | Complied with 21
CFR part 801 | Complied with 21
CFR part 801 | SE |
| Syringe Volume | | 5ml, 7ml, 10ml,
20ml, | 10ml | 10ml | Analysis
3 |
| Syringe
Connector Type | | Luer Lock, Luer Slip,
NRFit Lock, NRFit
Slip | Luer Lock ,Luer Slip | luer lock, NRFit
lock, | Analysis
2 |
| Syringe
Performance | | Complied with
ISO 7886-1
ISO 80369-6
ISO 80369-7 | Complied with
ISO 7886-1
ISO 80369-7 | Complied with
ISO 7886-1
ISO 80369-6
ISO 80369-7 | SE |
| Materials | | | | | |
| Syrin | Barrel | Polypropylene (PP) | Plastic material, detail | Plastic material, detail | Analysis 4 |
| ge | Plunger | Polypropylene (PP) | material of each | material of each | |
| | Piston | Silicone compound | component is
unknown | component is
unknown | |
| Biocompatibility | | | | | |
| Irritation | | No intracutaneous
reactivity | Complied with ISO
10993-1, detail | Complied with ISO
10993-1, detail | Analysis
4 |
| Sensitization | | No skin sensitization | testing items are
unknown | testing items are
unknown | |
| Systemic
Toxicity | | No systemic toxicity | unknown | unknown | |
| Hemolysis | | No Hemolysis | | | |
| Pyrogen | | No Pyrogen | | | |
| Sterilization | | | | | |
| Method | | EO Sterilized or
non-sterile | Unknown | EO Sterilized or
non-sterile | Analysis
5 |
| SAL | | 10-6 | 10-6 | 10-6 | |
| Endotoxin Limit | | 2.15 EU per device | Unknown | Unknown | |
9
Analysis 1 –Indications for Use and Product States
The proposed device and predicate devices have the same indications for use. They are all intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, and they all state that the syringe will be sold sterile individually
10
packaged, and as part of a sterile kit.
Both the proposed device and predicate device 2 supplied sterile product and non-sterile product. The sterile product is provided directly to the end user, and the non-sterile product will be provided to medical device manufactures to be sterilized and packaged. Therefore, we believe the final sentence of the indications for use, the syringe will be sold sterile individually packaged, and as part of a sterile kit, is appropriate.
Analysis 2-Configuration
The connect type between proposed device and predicate device 1 and 2 is different. The predicate device 1 has luer lock and luer slip connector, the predicate device 2 has luer lock and NRFit lock connector. Although the NRFit slip connector is not included in the predicate device, the NRFit slip connector of the proposed device meets the requirements of ISO 80369-6 standard. Therefore, this difference does not affect substantially equivalency on safety and effectiveness.
Analysis 3-Syringe Volume
The Syringe volume for proposed device is different from the predicate devices 1 and 2. However, this difference is just in dimension. Different volume device will be selected by physician per clinical condition. Additionally, the performance of syringe has been evaluated and the test results met the requirements of ISO 7886-1. Therefore, this difference on syringe volume does not raise new questions on the proposed device's safety and effectiveness.
Analysis 4-Patient-contact material and biocompatibility
The detail patient-contact material and biocompatibility testing items for predicate device1 and 2 is unknown. However, the biocompatibility test for proposed device has been conducted and the test results showed that there are no negative impacts from the materials that are used in the proposed device. In addition, we believe that the biocompatibility testing items are appropriate based on the contact level of the proposed device. Therefore, the differences on patient-contact material and biocompatibility testing items will not raise new questions on the proposed device's safety and effectiveness.
Analysis 5-Sterilization
The proposed device and the predicate devices have the same sterilization method and SAL. The endotoxin limit of the proposed device is 2.15EU, the endotoxin limit of predicate device 1 and 2 is unknown. Although the proposed device will not contact cerebrospinal fluid, its endotoxin limit still meets the requirement of 2.15EU. We believe the difference on endotoxin limit will not raise new questions on the proposed device's safety and effectiveness.
9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially
11
Equivalent (SE) to the predicatedevices.