(154 days)
The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.
The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1. The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube. J shape tube, which is used to draw contrast media/ saline into the syringe barrel. Spikes, which are used to draw contrast media/saline into the syringe barrel.
The provided document is a 510(k) premarket notification for a medical device: "Sterile High-pressure Angiographic Syringes for Single-use". This type of submission focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device, rather than proving novel effectiveness or safety through extensive clinical trials.
As such, the document does not describe a study to prove the device meets acceptance criteria in the way you've outlined for an AI-powered diagnostic device. Instead, it details non-clinical tests to show the proposed device performs comparably to the predicate and meets relevant engineering standards.
Therefore, many of your requested points regarding Acceptance Criteria and Study Proof (especially related to AI, MRMC, expert consensus, and ground truth establishment) are not applicable to this 510(k) submission for a non-AI medical device.
However, I can extract the relevant information from the document regarding the "acceptance criteria" (in the sense of standards compliance and comparative performance) and the "study" (non-clinical tests) that proves these criteria are met.
Here's a breakdown based on the provided document:
Device: Sterile High-pressure Angiographic Syringes for Single-use
Device Type: Non-AI Medical Device (Angiographic Syringes)
Study Purpose: To demonstrate Substantial Equivalence (SE) to a predicate device (Shenzhen BaoAn Medical Supplies Co., Ltd. Sterile High-pressure Angiographic Syringes for Single-use, K151960) through non-clinical testing and comparison.
1. A table of acceptance criteria and the reported device performance
For a non-AI device like this syringe, "acceptance criteria" primarily refer to adherence to recognized international standards and demonstration of comparable performance to a predicate device. "Reported device performance" is the outcome of non-clinical tests demonstrating compliance.
| Acceptance Criteria (Standard / Property) | Basis / Test Method | Reported Device Performance (Result & SE Justification) |
|---|---|---|
| Performance | ||
| Compliance with Syringe Standards | ISO 7886-1 (Sterile hypodermic syringes for single use), ISO 594-1 (Conical fittings with a 6% (Luer) taper), ISO 594-2 (Lock Fitting) | Complied with ISO 7886-1, ISO 594-1, and ISO 594-2. This demonstrates performance equivalent to the predicate. |
| Seal Strength | ASTM F88/F88M-15 (Standard test method for seal strength of flexible barrier materials) | Test results met the standard. |
| Seal Leaks (Porous Medical Package) | ASTM F1929-15 (Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration) | Test results met the standard. |
| Connection Tube Performance | ISO 594-1 and ISO 594-2 | Performance test results of connection tube meet the criteria. Even with more product specifications (various lengths), the performance is maintained. |
| J-shape Tube Leakage | Non-standardized test, implied to ensure functionality. | Performance test results showed no leaks. |
| Biocompatibility | ||
| Biocompatibility Assessment | ISO 10993-1: 2018 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process) | Overall biocompatibility demonstrated; differences in materials (e.g., Piston, Filter membrane) from predicate are deemed not to affect SE due to successful biocompatibility testing (Analysis 2). |
| Cytotoxicity | ISO 10993-5:2009 (Tests for In Vitro cytotoxicity) | No Cytotoxicity. (Same as predicate) |
| Irritation | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Irritation. (Same as predicate) |
| Sensitization | ISO 10993-10:2010 (Tests for irritation and skin sensitization) | No Sensitization. (Same as predicate) |
| Systemic Toxicity | ISO 10993-11:2017 (Tests for systemic toxicity) | No Acute Toxicity. (Same as predicate) |
| Hemolysis | ASTM F 756-17 (Standard practice for assessment of hemolytic properties of material) | No Hemolysis. (Same as predicate) |
| Pyrogenicity | USP 41-NF36:2018 <151> (Pyrogen Test (USP Rabbit Test)) | No Pyrogen. (Same as predicate) |
| Sterility & Particulate Matter | ||
| Bacterial Endotoxins Limit | USP 41-NF36 2018 <85> (Bacterial Endotoxins Limit) | Test results met the standard. |
| Sterility Assurance (Post-sterilization) | ISO 11737-2:2009 (Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process) | Test results met the standard. (EO sterilized, same as predicate). |
| Ethylene Oxide Sterilization Residuals | ISO 10993-7:2008 (Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals) | Test results met the standard. (EO sterilized, same as predicate). |
| Particulate Matter | USP <788> (Particulate matters) | Complied with USP 788. (Same as predicate) |
| Material & Physical Compatibility | ||
| Syringe Volume & Configuration Range Compatibility with Predicate's Performance | Comparison of various single and dual shot volumes (50ml to 200ml) and accessory types (connection tubes, J-shape tube, spikes) with the predicate device. | While the proposed device has a wider range of sizes/configurations than the predicate, non-clinical tests confirmed that all these configurations meet the performance criteria of relevant ISO standards. This difference is deemed not to affect SE. (Analysis 1) |
| Patient-Contact Material Compatibility | Comparison of materials used for various components (Barrel, Piston, Connection Tube, Luer Connectors, Spike, Filter Membrane, J-shape tube) with the predicate. Explicitly, changes in Piston (Medical rubber vs. Polyisoprene rubber) and Filter Membrane (Medical rubber vs. Polypropylene) from the predicate. | Differences in Piston and Filter Membrane materials exist. However, the contact classification (blood path, indirect limited contact) remains the same as the predicate. Extensive biocompatibility testing (Cytotoxicity, Irritation, Sensitization, Acute Toxicity, Hemolysis, Pyrogen) on the |
| proposed device's materials showed no adverse effects. Therefore, these material differences are not considered to affect substantial equivalence. (Analysis 2) | ||
| Labeling | 21 CFR Part 801 (Medical Device Labeling) | Complied with 21 CFR Part 801. (Same as predicate) |
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: The document does not explicitly state the number of units/samples used for each non-clinical test (e.g., how many syringes were tested for seal strength, or how many batches for endotoxin). It only states that "Non clinical tests were conducted to verify that the proposed device met all design specifications." The specific number of test replicates/samples would typically be detailed in the full test reports, which are not part of this summary document.
- Data Provenance: The tests are non-clinical (laboratory/bench testing) performed to verify compliance with standards. The company "Youwo (Guangzhou) Medical Device Co., Ltd." is based in Guangzhou, P.R. China, implying the testing was conducted in China, likely at their own facilities or certified labs in China. The data is entirely lab-generated, not from human subjects. The nature of the testing is prospective, in the sense that the tests were performed specifically for this submission on new device samples.
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)
- Not Applicable. This is a non-AI, non-diagnostic medical device. There is no concept of "ground truth" established by human experts in the context of diagnostic interpretation. The "ground truth" for the performance of these syringes is defined by the objective pass/fail criteria of the recognized engineering and biocompatibility standards (e.g., is the seal strong enough? Is there pyrogen presence?). Compliance is measured by laboratory equipment and established protocols, not expert human review of an image or signal.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 3, there's no human diagnostic interpretation to adjudicate. Test results are objective measurements against pre-defined thresholds from standards.
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 device is not an AI diagnostic tool, nor is it intended to assist human readers in interpreting medical cases. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device. Standalone performance refers to the device's ability to meet its specifications independently, which is what the non-clinical tests implicitly demonstrate (e.g., a syringe's seal strength is measured independently of human operation).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Standards-Defined Ground Truth: The "ground truth" here is the adherence to internationally recognized performance and safety standards (e.g., ISO, ASTM, USP). The device is "true" if it passes the specified tests according to the criteria defined within those standards. For example, a "true" biocompatible device produces no cytotoxicity according to ISO 10993-5. This is determined by laboratory measurements and chemical/biological assays, not clinical outcomes or expert diagnostician consensus.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device. There is no training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/machine learning device. No ground truth for a training set was established.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 28, 2020
Youwo (Guangzhou) Medical Device Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China
Re: K201395
Trade/Device Name: Sterile High-pressure Angiographic Syringes for single-use Regulation Number: 21 CFR 870.1650 Regulation Name: Angiographic Injector And Syringe Regulatory Class: Class II Product Code: DXT Dated: September 24, 2020 Received: September 25, 2020
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
{1}------------------------------------------------
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 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,
For CAPT Alan Stevens 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) K201395
Device Name
Sterile High-pressure Angiographic Syringes for Single-use
Indications for Use (Describe)
The proposed device is intended for the injection of contrast media or saline. This syringe use with US legally marketed angiographic injectors.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Tab 6 510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K201395
-
- Date of Preparation: 10/20/2020
-
- Sponsor Identification
Youwo (Guangzhou) Medical Device Co., Ltd.
First Floor and Fourth Floor, Building D, No.188 Kaiyuan Ave, Hi-tech Industrial Development Zone, 510530 Guangzhou, P.R. China
Establishment Registration Number: Not yet registered
Contact Person: Meijin Song Position: Quality Manager Tel: +86 20-81729108 Fax: +86 20-81242709 Email: dollars1008@163.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Huifan Wang (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd. P.O. Box 120-119, Shanghai, 200120, China
P.O. Box 126-119, Shanghai, 200126, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: Sterile High-pressure Angiographic Syringes for Single-use Common Name: Disposable angiographic syringe
Regulatory Information
Classification Name: Angiographic injector and syringe Classification: II Product Code: DXT Regulation Number: 21 CFR 870.1650 Review Panel: Cardiovascular
Indications for Use Statement:
The proposed device is intended for the injection of contrast media or saline. This syringe is for single use with US legally marketed angiographic injectors.
Device Description
The proposed devices are available in packs, which may include different configurations of syringes and accessories. The syringes are plastic, disposable syringes, which are available in various models and configurations. They are intended to be used with an U.S. legally marketed angiography injector, compatibilities are shown in Table 1.
| No | Model | Single or DualShots | Injector |
|---|---|---|---|
| 1 | I-50ml -B | Single | K091734 |
| 2 | I-60ml -A | Single | K890898 |
| 3 | I-60ml -B | Single | K984088 |
| 4 | I-65ml -A | Single | K033247 |
| 5 | I-100ml -B | Single | K091734 |
| 6 | I-115ml -A | Single | K033247 |
| 7 | I-150ml -A | Single | K132928 |
| 8 | I-190ml -A | Single | K023183 |
| 9 | I-200ml -A | Single | K023183 |
| 10 | I-200ml -B | Single | K091734 |
| 11 | II-125ml -A | Single | K052633 |
| 12 | II-150ml -A | Single | K903390 |
| 13 | II-200ml -A | Single | K031339 |
Table 1 Compatibility between Syringes and Injectors
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| 14 | I 200-200ml -A | Dual | K023183 |
|---|---|---|---|
| 15 | I 200-200ml -B | Dual | K091734 |
| 16 | I 115-115ml -A | Dual | K033247 |
| 17 | I 100-100ml -B | Dual | K091734 |
| 18 | I 100-200ml -B | Dual | K091734 |
| 19 | I 50-100ml -B | Dual | K091734 |
| 20 | I 50-200ml -B | Dual | K091734 |
| 21 | I 60-60ml -A | Dual | K890898 |
| 22 | I 60-60ml -B | Dual | K984088 |
| 23 | I 65-65ml -A | Dual | K935668 |
| 24 | I 65-115ml -A | Dual | K033247 |
| 25 | II 200-200ml -A | Dual | K031339 |
| 26 | I 190-190ml -A | Dual | K023183 |
| 27 | I 50-50ml -B | Dual | K091734 |
| 28 | II 100-100ml -B | Dual | K091734 |
| 29 | I 60-100ml -B | Dual | K052633 |
The connection tubes, which is used to connect the syringe and the catheter. The tubes are available in two configurations, which are Type Y and Type T tube. The different between these tubes is tube shape, which is available in Y shape for Y tube and T shape for T tube.
J shape tube, which is used to draw contrast media/ saline into the syringe barrel.
Spikes, which are used to draw contrast media/saline into the syringe barrel.
- ર : Identification of Predicate Device
510(k) Number: K151960
Product Name: Sterile High-pressure Angiographic Syringes for Single-use Manufacturer: Shenzhen BaoAn Medical Supplies Co., Ltd.
-
- Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- Non-Clinical Test Conclusion
-
ISO 10993-7:2008 Biological evaluation of medical devices- Part 7: Ethylene oxide sterilization residuals;
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-
ASTM F88/F88M-15 Standard test method for seal strength of flexible barrier materials;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration;
-
USP 41-NF36 2018 <85> Bacterial Endotoxins Limit;
-
ISO 11737-2:2009 Sterilization of medical devices- Microbiological methods- Part 2: Test of sterility performed in the definition, validation and maintenance of a sterilization process;
-
ISO 7886-2:1996 Sterile hypodermic syringes for single use -- Part 2: Syringes for use with power-driven syringe pumps;
-
ISO 594-1:1986 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General Requirements;
-
ISO 594-2:1998 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock Fitting:
-
ISO 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
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;
- A ISO 10993-11:2017 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity;
-
USP <788> Particulate matters
-
ASTM F 756-17, Standard practice for assessment of hemolytic properties of material
-
USP 41-NF36:2018 <151> Pyrogen Test (USP Rabbit Test)
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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8. Substantially Equivalent (SE) Comparison
| Proposed Device | Predicate DeviceK151960 | Remark | |
|---|---|---|---|
| ITEM | |||
| Product Code | DXT | DXT | Same |
| Regulation No. | CFR 870.1650 | CFR 870.1650 | Same |
| Class | II | II | Same |
| Intended Use | The proposed device is intendedfor the injection of contrastmedia or saline. This syringe isfor single use with US legallymarketed angiographic injectors. | The proposed device is intendedfor the injection of contrastmedia or saline. This syringe isfor single use with US legallymarketedangiographicinjectors. | Same |
| Mode ofOperation | Power-Driven | Power-Driven | Same |
| Angiographic Syringe | Angiographic Syringe | Same | |
| Configuration | Connection tube | Connection tube | Same |
| J shape tube/ Spike | J shape tube/Spike | Same | |
| Specification | |||
| Syringe volume(ml) | Single shot: 50, 60, 65, 100, 115,150, 190, 200, 125Dual shot: 200/200,115/115,100/100,100/200,50/100,50/200, 60/60, 65/65, 65/115,190/190, 50/50, 60/100 | Single shot: 200, 150, 130Dual shot: 200/200, 65/65,65/115, 60/60, 60/100 | |
| Connection tubelength (mm) | 300, 500, 600, 750, 900, 1000,1200, 1500, 1800, 2000, 2500,3200 | 1500, 1800, 500, 700, 1000,1200 | Analysis 1 |
| Spike length(mm) | 36, 39, 44, 49 | 58.85, 47.35 | |
| J shape tubelength (mm) | 250 | 240 | |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Performance | Comply with:ISO 7886-1, ISO 594-1 and ISO594-2 | Comply with:ISO 7886-1, ISO 594-1 and ISO594-2 | Same |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Irritation | No Irritation | No Irritation | Same |
| Sensitization | No Sensitization | No Sensitization | |
| Acute Toxicity | No Acute Toxicity | No Acute Toxicity | |
| Hemolysis | No Hemolysis | No Hemolysis | |
| Pyrogen | No Pyrogen | No Pyrogen | |
| Particulate testing | Comply with USP 788 | Comply with USP 788 | Same |
| Sterilization | EO Sterilized | EO Sterilized | Same |
| Patient-contact material- Angiographic syringe | |||
| Barrel | polypropylene (PP) orPolyethylene terephthalate(PET) | polypropylene (PP) orPolyethylene terephthalate(PET) | Same |
| Piston | Medical rubber | Polyisoprene rubber | Analysis 2 |
| Patient-contact material-Connection tube | |||
| Tube | polyvinyl chloride (PVC) | polyvinyl chloride (PVC) | Same |
| Luer connectors | Polycarbonate (PC) | Polycarbonate (PC) | Same |
| Patient-contact material-Spike and J shape tube | |||
| Closure-piercing device | acrylonitrile-butadiene-styrene(ABS) | acrylonitrile-butadiene-styrene(ABS) | Same |
| Filter membrane | Medical rubber | Polypropylene (PP) | Analysis 2 |
| J shape tube | Polyethylene (PE) | Polyethylene (PE) | Same |
Table 2 General Comparison
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Analysis 1
Although the proposed device has more product specification than that of the predicate device, the performance test results of syringes meet the criteria of ISO 7886-1, ISO 594-1 and ISO 594-2. The performance test results of connection tube meet the criteria of ISO 594-1 and ISO 594-2. The performance test results of shape tube showed no leaks. Therefore the specification difference is considered not to affect the Substantially Equivalency (SE) between the proposed and predicate device.
Analysis 2
The patient contact material of piston and filter membrane for the proposed device is different from predicate device. However, the contact classification for the proposed device is same as the predicate device, both of them belong to blood path and indirect limited contact. In addition, biocompatibility tests which include Cytotoxicity, Irritation, Sensitization, Acute Toxicity, Hemolysis and Pyrogen have been evaluated for the proposed device and the test result does not show any adverse effects. Therefore, this difference is not considered to affect substantially equivalence.
-
- Substantially Equivalent (SE) Conclusion
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Based on the comparison above, the proposed device, Sterile High-pressure Angiographic Syringes for Single-use, is determined to be Substantially Equivalent (SE) to the predicate device.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.