The proposed device, AquaFlate Pre-Filled Sterile Water Syringe 10mL (REF 250-400), is a 10mL syringe prefilled with USP purified water and sterilized via gamma irradiation. The syringe consists of a polypropylene barrel and plunger and latex free rubber for both the plunger gasket and syringe tip cap.

The AquaFlate Pre-Filled Water Syringe 10mL is intended for inflating an indwelling. urethral Foley catheter balloon. In accordance with CDC Guidelines, healthcare facility protocols, and the Foley catheter manufacturer's instructions for use, prior to catheterization, the syringe cap of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.

The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.

The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.

HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.

AI/ML Overview

The provided text describes the 510(k) summary for the AquaFlate Pre-Filled Sterile Water Syringe 10mL. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets a specific set of acceptance criteria for a new and novel AI/ML-driven medical device. Therefore, much of the requested information regarding acceptance criteria, specific study design for AI/ML performance, ground truth establishment, expert involvement, and statistical comparisons is not applicable to this type of regulatory submission.

However, I can extract the information relevant to the performance data and equivalence claims made for this product.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Instead of AI/ML performance metrics, the "acceptance criteria" here refer to conformance with established industry standards and regulations for medical devices of this type. The reported device performance is its successful adherence to these standards.

Acceptance Criteria (Standard / Test)	Reported Device Performance
Bench Testing
Small-bore connector testing ISO 80369-7:2016	Conforms
Manual, single-use syringe testing - ISO 7886-1:2017	Conforms
Sterility USP 42 Chapter <71> Sterility Tests	Conforms
Biocompatibility Testing
Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014	Yielded acceptable results
Irritation ANSI/AAMI/ISO 10993-10:2013	Yielded acceptable results
Sensitization - ANSI/AAMI/ISO 10993-10:2013	Yielded acceptable results
Sterilization
ANSI/AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013 (Radiation, Part 1)	Validated for gamma irradiation (25kGy min, 40kGy max) to achieve SAL of 10^-6
ANSI/AAMI/ISO 11137-2:2013 (Radiation, Part 2)	Validated
ANSI/AAMI/ISO 11137-3:2006 (R) 2010 (Radiation, Part 3)	Validated
ANSI/AAMI/ISO 11737-1: 2018 (Microbial Population)	Validated
ANSI/AAMI/ISO 11737-2: 2009 (R) 2014 (Sterility Tests)	Validated
AAMI TIR 17-2008 (Material Compatibility)	Validated
ANSI/AAMI/ISO TIR13004: 2013 (Radiation, Dose Substantiation)	Validated
Packaging Validation and Shelf Life
ISTA Procedure 3A (2018) Series (Parcel Delivery)	Underwent testing to support one-year shelf life
ASTM D4169-16 (Shipping Containers)	Underwent testing to support one-year shelf life
ASTM F1980-16 (Accelerated Aging)	Underwent testing to support one-year shelf life
Technological Characteristics Comparison to Predicate Device (AMSure Prefilled Syringe K181814)	Declared "Same" for Intended Use, Technological Characteristics, Materials, Physical Characteristics, Performance Specifications, Quantity, Sterility, Biocompatibility, Principle of Operation, Technical Performance, Utility, Sterility (Method), Environment of Use, Labeling. "Different" for Shelf Life (1 year vs. 3 years).

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each of the testing protocols (e.g., how many syringes were tested for sterility, or how many materials were tested for biocompatibility). It broadly states that "performance testing conducted per HR Pharmaceuticals' protocols" and that validation was performed. These are not "test sets" in the AI/ML context, but rather samples used for engineering and quality control validation.
Data Provenance: Not applicable in the context of typical AI/ML data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer and third-party labs according to recognized consensus standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This device is a pre-filled sterile water syringe, not an AI/ML diagnostic or therapeutic device. Ground truth, in the AI/ML sense, is not established by human experts for basic device functionality and safety testing like biocompatibility or sterility. Conformance to standards is the "ground truth" here.

4. Adjudication Method for the Test Set

Not Applicable. As this is not an AI/ML device, there's no diagnostic output requiring adjudication. Test results (e.g., pass/fail for a sterility test) are objective and determined by the methodology of the standard.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This is not an AI/ML device. No human reader studies or comparative effectiveness studies with AI assistance were performed or are relevant.

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

Not Applicable. This is not an AI/ML device. No algorithm-only performance testing was conducted.

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

The "ground truth" for this device's performance, safety, and effectiveness is established by conformance to recognized consensus standards and regulations (e.g., ISO for connectors, USP for sterility, ISO for biocompatibility, ASTM/ISTA for packaging). These standards define acceptable limits and methodologies.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device; therefore, there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

Summary

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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, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font in blue.

March 31, 2020

HR Pharmaceuticals, Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114

Re: K200556

Trade/Device Name: AquaFlate Pre-Filled Sterile Water Syringe 10mL Regulation Number: 21 CFR 876.5130 Regulation Name: Urological catheter and accessories Regulatory Class: II Product Code: EZL Dated: March 2, 2020 Received: March 3, 2020

Dear Prithul Bom:

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

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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,

Jessica K. Nguyen, Ph.D. Acting Assistant Director DHT3B: Division of Reproductive. Gynecology and Urology Devices 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200556

Device Name

AquaFlate Pre-filled Sterile Water Syringe 10 mL

Indications for Use (Describe)

The AquaFlate Pre-filled Sterile Water Syringe is intended to be used for inflating a Foley catheter balloon.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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K200556 Page 1 of 6

510(k) SUMMARY 5-1

5.0 510(k) SUMMARY

510(k) SUMMARY for AquaFlate Pre-Filled Sterile Water Syringe 10mL

I. SUBMITTER:

HR Pharmaceuticals, Inc. 2600 Eastern Boulevard, Suite 201 York, PA 17402

Telephone Number:717-252-1110 x104 Fax Number:717-685-2590

Contact Person: Colby Wiesman Date Prepared: November 26, 2019

II. DEVICE:

Name of Device: AquaFlate Pre-Filled Sterile Water Syringe 10mL Model Number: 250-400 Common or Usual Name: Catheter, Retention type, balloon Classification Description: Urological catheter and accessories (21 CFR 876.5130) Regulatory Class: II Product Code: EZL Review Panel: Gastroenterology/Urology

III. PREDICATE DEVICES:

AMSINO INTERNATIONAL, AMSure® Prefilled Syringe for Balloon Inflation with Sterile Water, K181814

No reference devices were used in this submission.

IV. DEVICE DESCRIPTION:

Image /page/3/Picture/17 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H-R" in a stylized font. To the right of the letters is the text "Pharmaceuticals, Inc." The logo is simple and professional, and it is likely used on the company's website, marketing materials, and products.

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removed and the luer tip of the syringe is connected to the inflation port of the catheter. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. A fter balloon inflation, the syringe is disconnected from the catheter inflation port and discarded.

The AquaFlate Pre-Filled Sterile Water Syringe 10mL is not intended for injection and is for single use only.

The shelf life of the AquaFlate Pre-Filled Sterile Water Syringe 10mL is one (1) year.

HR Pharmaceuticals does not intend to market this device with accessories or as part of a system.

V. INDICATIONS FOR USE:

The AquaFlate Pre-Filled Sterile Water Syringe 10mL is intended to be used for inflating a Foley catheter balloon.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES:

The subject and predicate devices have the same technological principle whereby, the prefilled sterile water syringe is intended for inflating an indwelling, urethral Foley catheter balloon. Once the catheter is inserted into the bladder, the entire contents of the syringe are dispensed to inflate the catheter balloon to ensure the catheter does not slide out. After balloon inflation, the syringe is disconnected from the catheter inflation port and discarded. Additionally, the prefilled sterile water syringe is not intended for injection and is for single use only.

At a high level, the AquaFlate Pre-Filled Sterile Water Syringe 10mL and the predicate device are based on the following same elements:

Same Intended Use
Same Technological Characteristics ●
Same Materials
. Same Physical Characteristics
Same Performance Specifications ●
Packaged in the same quantity (10mL) ●
o Provided sterile
Biocompatible

The only identified difference between the subject and predicate devices is the shelf life. The AquaFlate Pre-Filled Sterile Water Syringe 10mL has a one-year shelf life whereby, AMSure® Prefilled Syringe for Balloon Inflation with Sterile Water has a three-year shelf life. While the AquaFlate Pre-Filled Sterile Water Syringe 10mL is currently undergoing 2 year and 3-year shelf life testing, the one-year established shelf life for the subject device is acceptable for the intended use as demonstrated by successful stability

Image /page/4/Picture/21 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a flower. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.

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and performance testing. Therefore, the difference in shelf life between the subject and predicate devices does not raise new questions of safety or effectiveness.

A more detailed comparison of the predicate and subject devices is presented in the table below.

	Proposed DeviceAquaFlate Pre-Filled SterileWater Syringe 10mL	Predicate DeviceAMSure PrefilledSyringe for BalloonInflation with SterileWater(K181814)	Comparison
Manufacturer	HR Pharmaceuticals, Inc.	Amsino International, Inc.	N/A
Device ClassificationName	Catheter, Retention Type,Balloon	Catheter, Retention Type,Balloon	Same
Regulation Description	Urological catheter andaccessories	Urological catheter andaccessories	Same
Review Panel	Gastroenterology/Urology	Gastroenterology/Urology	Same
Product Code	EZL	EZL	Same
Reg Number	876.5130	876.5130	Same
Class	II	II	Same
Indications for Use	The AquaFlate Pre-Filled SterileWater Syringe 10mL is intendedto be used for inflating a Foleycatheter balloon.	Prefilled Syringe forBalloon Inflation withSterile Water is intendedto be used in inflatingfoley catheter balloon.	Same
Patient-contactingmaterial	Indirect patient contact of sterilewater used to inflate a catheterballoon	Indirect patient contact ofsterile water used toinflate a catheter balloon	Same
Sizes	10mL	10cc and 30cc	Same(10mL)
Materials ofMainComponents	Barrel	Polypropylene	Polypropylene	Same
	Plunger	Polypropylene	Polypropylene	Same
	PlungerGasket	Isoprene (black synthetic rubberthat does not contain naturalrubber latex)	Black pharmaceuticalgrade,synthetic rubber (Latexfree)	Same
	TipCover	Isoprene (black synthetic rubberthat does not contain naturalrubber latex)	Same as gasket	Same
	Solution	Purified water, USP	Purified water, USP	Same
Principle of Operation		Manual	Manual	Same
Technical Performance		Conforms with ISO7886-1,ISO 80369-7 and USP 42Chapter <71>	Conforms with ISO7886-1,ISO 80369-7 and USP 40	Same
Biocompatibility		Meets ISO 10993-1:2009requirements for irritation (ISO10993-10), sensitization (ISO	Conforms with ISO10993-5 and ISO 10993-10	Same
	Proposed DeviceAquaFlate Pre-Filled SterileWater Syringe 10mL	Predicate DeviceAMSure PrefilledSyringe for BalloonInflation with SterileWater(K181814)	Comparison
	10993-10), and cytotoxicity(ISO 10993-5)
Utility	Single Use	Single Use	Same
Sterility (Method)	Sterile (Gamma Irradiation)	Sterile (Gamma Irradiation)	Same
Environment of Use	Healthcare Facility	Healthcare Facility	Same
Labeling	Prescription Use	Prescription Use	Same
Shelf Life	1 year	3 years	Different
Device Picture	Image: syringe	Image: syringes	N/A

Image /page/5/Picture/6 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a flower. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the "R".

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*Values obtained from performance testing conducted per HR Pharmaceuticals' protocols.

VII. PERFORMANCE DATA

There are no FDA device-specific guidance documents, special controls document, and/or requirements in a device-specific regulation for prefilled sterile water syringes. Additionally, no performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for prefilled sterile water syringes. However, the following performance data were provided in support of the substantial equivalence determination.

Bench Testing

Small-bore connector testing ISO 80369-7:2016. Small-bore connectors for ● liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications [FR Recognition No. 5-115]
Manual, single-use syringe testing - ISO 7886-1:2017, Sterile hypodermic syringes for single use - Part 1: Syringes for manual use [FR Recognition No. 6-404]
Sterility USP 42 Chapter <71> Sterility Tests [FR Recognition No. 14-532] ●

Biocompatibility Testing

The biocompatibility evaluation for the AquaFlate Pre-Filled Sterile Water Syringe 10mL was conducted in accordance with the FDA Final Guidance "Use of International Standard ISO-10993, 'Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process, " June 16, 2016, and International Standard ISO 10993-1:2009 "Biological Evaluation of Medical Devices - Part 1: Evaluation and

Image /page/6/Picture/13 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a circle. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the letters.

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Testing Within a Risk Management Process," as recognized by FDA. The biocompatibility testing included the following and yielded acceptable results:

Cytotoxicity ANSI/AAMI/ISO 10993-5:2009 (R) 2014 Biological Evaluation of ● Medical Devices Part 5: Tests for In Vitro Cytotoxicity [FR Recognition No. 2-245]
Irritation ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical . Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-1741
. Sensitization - ANSI/AAMI/ISO 10993-10:2013—Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization [FR Recognition No. 2-174]

The AquaFlate Pre-Filled Sterile Water Syringe 10mL falls into the category of limited (<24 hour) external communicating devices and is intended for indirect tissue contact.

Sterilization

The AquaFlate Pre-Filled Sterile Water Syringe 10mL was validated for sterilization using gamma irradiation at a minimum dose of 25kGy and a maximum dose of 40kGy to achieve a Sterility Assurance Level of 10th in accordance with the following recognized standards:

ANSI/ AAMI/ISO 11137-1:2006/(R) 2015 & A1:2013. Sterilization of health ● care products -Radiation-Part1: Requirements for development validation, and routine control of a sterilization process for medical devices. [FR Recognition No. 14-4281
ANSI/AAMI/ISO 11137-2:2013. Sterilization of health care products-Radiation-Part 2: Establishing the sterilization dose. [FR Recognition No. 14-4091
ANSI/AAMI/ISO 11137-3:2006 (R) 2010. Sterilization of healthcare products -Radiation-Part 3: Guidance on dosimetric aspects. [FR Recognition No. 14-510]
ANSI/AAMI/ISO 11737-1: 2018. Sterilization of health care products, Microbiological Methods-Part 1: Determination of a population of microorganisms on product. [FR Recognition No. 14-514]
ANSI/AAMI/ISO 11737-2: 2009 (R) 2014. Sterilization of Medical Devices-● Microbiological Methods-Part 2: Tests of sterility Performed in the definition, validation and maintenance of a sterilization Process. [FR Recognition No. 14-327]
AAMI TIR 17-2008. Compatibility of Materials subject to sterilization. ●
ANSI/AAMI/ISO TIR13004: 2013. Sterilization of health care products-● Radiation-Substantiation of a selected sterilization dose-Method VDmax®

Image /page/7/Picture/17 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet inside of a circle. The text "Pharmaceuticals, Inc." is to the right of the "R" and the water droplet symbol.

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Packaging Validation and Shelf Life

The AquaFlate Pre-Filled Sterile Water Syringe 10mL underwent packaging validation testing and accelerated aging testing per the below standards to support a one-year shelf life.

ISTA Procedure 3A (2018) Series. General Simulation Performance Test Procedure Packaged-Products for Parcel Delivery System Shipment 150lb or less.
ASTM D4169-16. Performance Testing of Shipping Containers and Systems ● [FR Recognition No. 14-499]
ASTM F1980-16. Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices [FR Recognition No. 14-497]

VIII. CONCLUSION

All necessary testing has been performed on the AquaFlate Pre-Filled Sterile Water Syringe 10mL to support the safety and effectiveness of the device per its intended use. Additionally, the performance testing concluded that the subject device is substantially equivalent to the legally marketed predicate device.

Image /page/8/Picture/10 description: The image shows the logo for H-R Pharmaceuticals, Inc. The logo is in blue and features the letters "H" and "R" in a stylized font. To the right of the "R" is a symbol that looks like a water droplet above a plant. The words "Pharmaceuticals, Inc." are written in a smaller font to the right of the "R".

Regulation Number and Section

§ 876.5130 Urological catheter and accessories.

(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.