The Orbit Subretinal Delivery System is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit. All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components: Subretinal Injection Cannula, Ophthalmic Marker, Syringes, and Tubing Set. The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use. Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	In accordance with ISO 10993-01 standards (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity)	Product performance met all prior established acceptance criteria.
Sterilization (Injection Cannula Set & Tubing Set)	Sterility Assurance Level (SAL) of 10-6 in accordance with ANSI/AAMI/ISO 11137-2:2013	Testing demonstrated product performance met all prior established acceptance criteria.
Sterilization (Syringe Set)	In accordance with ISO 11135:2014; EO and ECH residuals within acceptable limits.	Testing demonstrated product performance met all prior established acceptance criteria.
Cleaning and Disinfection (Third Arm Kit)	Meets established cleaning and disinfection requirements per FDA Guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"	Confirmed that the Third Arm Kit meets the established cleaning and disinfection requirements.
Packaging Qualification (Subretinal Access Kit)	Whole package physical integrity requirements and seal integrity requirements met.	Met.
Real-time Shelf Life (Subretinal Access Kit)	Establishes expiration date.	29 month expiration date established.
Post-Distribution Performance: Syringe Set	Visual inspection of device and package integrity testing.	All tests passed pre-established test criteria.
Post-Distribution Performance: Tubing Set	Leak pressure, tensile strength, dimensional integrity.	All tests passed pre-established test criteria.
Post-Distribution Performance: Subretinal Injection Cannula Set	Flexural stiffness, flow rate, dimensional integrity, assembly tensile strength, and leak pressure.	All tests passed pre-established test criteria.
Simulated Use (Subretinal Delivery Device)	Confirmation of saline injection forming a subretinal bleb.	Successfully performed; injections formed subretinal blebs.
Functionality (Third Arm Kit)	Verification of stability to the injection cannula during use, dose clip delivery accuracy, and device durability.	All tests passed.
Overall Product Design Requirements & Applicable Standards	Meets all product design requirements and applicable standards.	Met.

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

Sample Size:
- Simulated use evaluation: Eight (8) procedures were conducted in a porcine model.
- Specific sample sizes for other tests (e.g., biocompatibility, sterilization, packaging) are not detailed in the provided document. The document states "Testing demonstrated product performance met all prior established acceptance criteria," implying that adequate samples were used for these regulatory tests, but the numbers themselves are not specified.
Data Provenance: The simulated use test was performed in a porcine model, indicating animal testing. The document does not specify the country of origin for the data, nor does it explicitly state whether it was retrospective or prospective. Given the nature of medical device validation testing, it would generally be prospective.

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

The document describes laboratory and animal model testing, not human clinical studies involving expert observers to establish ground truth in the way one might for diagnostic AI.
For the simulated use evaluation, the procedures were performed in a porcine model. It is implied that qualified personnel (e.g., surgeons, researchers) carried out these procedures and observed the results (formation of subretinal blebs), but the number and specific qualifications of these individuals are not stated.

4. Adjudication Method for the Test Set

The document describes engineering and simulated use testing, not a scenario where human observers would require an adjudication method for ground truth. Observations from the simulated use evaluation (formation of subretinal blebs) are presumably directly observable outcomes rather than requiring expert consensus. Therefore, an adjudication method in the context of expert consensus is not applicable/described.

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

No, an MRMC comparative effectiveness study was not done. The Orbit Subretinal Delivery System is a physical medical device (a microinjection system), not an AI algorithm or a diagnostic tool that assists human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a manual ophthalmic surgical instrument designed for human operators; it is not an algorithm, and therefore, standalone algorithmic performance is not relevant.

7. The Type of Ground Truth Used

For the simulated use evaluation, the "ground truth" was the direct observation of the physical outcome: the successful formation of a subretinal bleb after injection into a porcine model.
For other tests like biocompatibility, sterilization, and performance testing, the ground truth refers to established scientific and regulatory standards (e.g., ISO standards, FDA guidance, pre-established test criteria) that define acceptable performance.

8. The Sample Size for the Training Set

Not applicable. The Orbit Subretinal Delivery System is a physical medical device, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, this is not an AI model requiring a training set.

Summary

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Image /page/0/Picture/0 description: The image contains 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.

November 20, 2018

Orbit Biomedical, Inc. % Judy Gordon Regulatory Affairs Consultant ClinReg Consulting Services, Inc. 733 Bolsana Drive Laguna Beach, CA 92651

Re: K182274

Trade/Device Name: Orbit Subretinal Delivery System Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, HMX Dated: September 14, 2018 Received: September 17, 2018

Dear Judy Gordon:

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 avare 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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. 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.

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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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Alexander Beylin -S 2018.11.20 14:06:07 -05'00'

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K182274

Device Name

Orbit Subretinal Delivery System

Indications for Use (Describe)

The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

Type of Use (Select one or both, as applicable)

☑ Remediation Use (Part 31, SER 201, Subpart D)	☐ Generic Use (Part 31, SER 201, Subpart J)
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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(a).

APPLICANT:	Orbit Biomedical Inc.300 Brookside Ave.Ambler, PA 19002
OFFICIAL CORRESPONDENT:	Judy F. Gordon, D.V.M.ClinReg Consulting Services, Inc.733 Bolsana DriveLaguna Beach, CA 92651Tel: (949) 715-0609judy@clinregconsulting.com
DATE SUMMARY PREPARED:	November 20, 2018
SIGNATURE:	Image: Signature
TRADE NAME:	Orbit Subretinal Delivery System
COMMON NAME:	Manual Ophthalmic Surgical Instrument
DEVICE CLASSIFICATION / CODE:	FMF, Syringe, PistonClass II21 CFR 880.5860
SECONDARY PRODUCT CODE:	HMX, Ophthalmic Cannula
PREDICATE DEVICE:	K023752BD Integra 1mlSyringeClass II21 CFR 880.5860FMF
REFERENCE DEVICE:	K010305Weiss Retinal CannulaMicron Surgical, Inc.Class I21 CFR 886.4350HMX

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DEVICE DESCRIPTION

The Orbit Subretinal Delivery System (Figure 1) is designed for microinjection into the subretinal space. The Orbit Subretinal Delivery System is comprised of 2 kits: the Subretinal Access Kit and the Third Arm Kit.

Image /page/4/Picture/3 description: The image shows a medical device with a clamp at the bottom and a probe extending from the top. The device has multiple adjustable arms and joints, allowing for precise positioning of the probe. A thin tube connects to the probe, likely for delivering fluids or medication. The device appears to be designed for minimally invasive procedures, providing targeted access to specific areas of the body.

Figure 1: Orbit Subretinal Delivery System

All Subretinal Access Kit components are supplied sterile and intended for single-use only and cannot be reused or resterilized. The Subretinal Access Kit contains the following device components:

Subretinal Injection Cannula: A sterile flexible ophthalmic cannula with an advanceable needle is used for subretinal access via the suprachoroidal space. The Subretinal Injection Cannula allows for consecutive injections. The first subretinal injection delivers either Balanced Salt Solution (BSS) or BSS® PLUS to create an "entry bleb" in the desired subretinal location. The second subretinal injection delivers a specific treatment "dose" (i.e., quantity) of BSS or BSS® PLUS into the entry bleb that was created with the first injection. The advanceable needle is available in 2 different configurations: straight or curved.

Ophthalmic Marker: A custom sterile ophthalmic marker is provided and is intended to be used with a commercially available sterile gentian violet ink marking pad. The marker is used to stain the sclera for positioning of suture loops and scleral incision.

Syringes: Two (2) identical sterile syringes (1 mL each) are provided, one for each fluid line: BSS line (used to create an entry bleb) and the DOSE line (used to deliver the BSS or BSS® PLUS treatment dose). Each syringe includes a barrel, a plunger rod, and a piston.

Tubing Set: An optional tubing set is supplied with each kit to allow the user the ability to connect to a commercially available vitreoretinal surgical console for pneumatic injection (vs. manual injection). A sterile tubing set connects to the 1 mL syringe and interfaces with the pressure regulator functionality of vitreoretinal surgical consoles.

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The assembled Third Arm Kit functions as a "third arm" to stabilize the subretinal injection cannula and free the surgeon's hands during the procedure. The Third Arm Kit (supplied nonsterile) is reusable and must be cleaned and sterilized prior to each use.

Together, the Subretinal Access Kit and the Third Arm Kit are to deliver the infusate (e.g., BSS. BSS® PLUS) to the subretinal space as described in the Instructions for Use.

INDICATIONS FOR USE

The Orbit Subretinal Delivery System is indicated for microinjection into the subretinal space.

TECHNOLOGICAL CHARACTERISTICS COMPARISON

The technical features of the Subretinal Delivery System components are substantially equivalent to the features and intended use of the BD 1ml syringe (K023752), as well as the Weiss Retinal Cannula (K010305). The Subretinal Delivery System is manually operated for the controlled delivery of small amounts of fluid dispensed on the principle of exchanging volumes with the use of a piston syringe that has the same features and intended use of the predicate piston syringe.

The primary similarities and differences for the predicate device include:

Syringe configuration The syringe component of the Orbit Subretinal Delivery System . shares the same primary components (i.e. syringe barrel, plunger and piston). The primary technological difference between the proposed and the predicate syringe devices is that the proposed device utilizes an injection cannula for fluid delivery instead of the needle connected to the syringe itself (predicate).
. Syringe operating principle - Both the proposed and predicate syringe(s) are manually operated by the user through the advancement and/or withdrawal of the syringe plunger within the barrel. Syringe content volume can be controlled by the user for both the proposed and predicate devices. These operating principles are identical to the vast majority of piston syringes currently on the market.

The technical features of the Orbit Subretinal Delivery System is also substantially equivalent to the Weiss Retinal Cannula which is presented as a reference device.

The primary similarities and differences for these devices include:

Cannula Tip design The rounded tip design of the Orbit cannula design is similar to the ● design of the reference device, which is designed for insertion. The Orbit cannula tip is made from a more flexible and lubricious material that contours more closely to the globe for smoother entry into the suprachoroidal space. Materials chosen for the proposed and reference devices are medical grade and were tested for biocompatibility.

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Needle advancement As with the reference device however the SRDS needle rotates in ● order to advance vs. the slide mechanism of the reference device. The user has finer control of the needle advancement by this screw mechanism.
. The differences between the design of the subretinal cannula component of the Orbit Subretinal Access Kit and the Weiss Retinal Cannula (reference device) is that the proposed device is also provided with an ophthalmic marker and a reusable cannula holder, called the Third Arm Kit that frees the surgeon's hands during the procedure.

The Orbit Subretinal Injection Cannula and the Weiss Retinal Cannula provide a cylindrical fluid pathway designed to administer pre-assigned fluid volumes to the subretinal space.

The minor differences in design features or technological characteristics between the Orbit Subretinal Delivery System and the predicate and reference devices do not introduce new or unique potential adverse events (i.e., hazards) and therefore does not raise new issues of safety and effectiveness.

Table 1 on the following page provides additional comparison between the components of the proposed device (Orbit Subretinal Delivery System) and the predicate and reference devices.

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TABLE 1 DEVICE COMPARISON

Feature	Orbit Subretinal Delivery SystemProposed Device	BD Integra 1mL SyringeK023752Predicate Device	Weiss Retinal CannulaK010305Reference Device
Manufacturer	Orbit Biomedical, Inc.	BD	Micron Surgical, Inc.
Device Classification	Class II	Class II	Class I
Device Product Code	FMF; HMX	FMF	HMX
Regulation Description	Cannula, Ophthalmic	Syringe, Piston	Cannula, Ophthalmic
Regulation	21 CFR 886.4350	21 CFR 880.5860	21 CFR 886.4350
Indications for Use	The Orbit Subretinal Delivery System isindicated for microinjection into thesubretinal space.	The BD Integra Syringe is used foraspiration of fluids from vials andampoules and a variety of fluidinjections below the surface of the skin.1	The Weiss Retinal Cannula is usedfor microinjection into thesubretinal space, intraretinal spaceor intravascular retinal space.
Syringe
Purpose	Single use, small amounts of fluidinjection	Same	N/A
Configuration	Standard 3-piece piston syringeconstructed with a barrel, piston, plunger	Same	N/A
Operation Mode	Manually operated by the advancementof the syringe plunger within the barrel	Same	N/A
Materials	Common materials chosen, medicalgrade, low extractable polymer	Not disclosed in510(k) summary	N/A
Volume	l mL; controlled through dose clips	1 ml; user controlled by use of depthmarkings	N/A
Biocompatibility	ISO 10993-1 compliance	Same	N/A
Feature	Orbit Subretinal Delivery SystemProposed Device	BD Integra 1mL SyringeK023752Predicate Device	Weiss Retinal CannulaK010305Reference Device
Sterilization	EOSterility Assurance Level (SAL) 10⁻⁶	Not disclosed in510(k) summary	N/A
Subretinal Injection Cannula
Flexible Ophthalmic Cannula	YES	N/A	YES
Suprachoroidal Cannulation	YES	N/A	Unknown
Advanceable Needle	YES	N/A	YES
Subretinal Access and subretinalinjection	YES	N/A	YES
Catheter/Cannula materials ofmanufacture	PEBAX/PROPELL (outer sheath),Stainless Steel (insert)	N/A	304 Stainless steel, polyester tubing(outer sleeve)
Catheter/Cannula dimensions	1.6mm x 8mm (oval cross section)	N/A	200 microns
Advanceable needle materials ofmanufacture	Nitinol	N/A	Borosilicate glass
Advanceable needle size	0.012 in (approx. 305 microns) OD	N/A	70 microns OD / 50 microns ID
Needle/cannula advancingmechanism	Mechanical: Rotating knob and internalcam for linear translation	N/A	Retraction of polymeric tube toexpose microneedle
Needle/cannula full extension length	Up to 4.5 mm	N/A	3 mm
Infusion line material	Tecoflex 72A (polyurethane)	N/A	Polyethylene
Atraumatic features	Molded tip, retractable needle, lubriciouscannula material (PROPELL, withinsheath material)	N/A	Retractable needle, polymerictubing
Infusion port	Luer connector	N/A	Luer connector
Depth markings	5-20mm in 5mm increments	N/A	Unknown
Provided single use, sterile packed	YES except for Third Arm Kit	YES	YES
Sterilization method	Gamma (subretinal injection cannula set,tubing set)	Not disclosed in 510(k) Summary	Ethylene Oxide

1 Complete Indications for Use. The BD Integral" Syrings of fluids from vials and anpoules and a variety of fluid injections below the skin. It is not intended to be used for phlebotony. The in insulin unis and is used for insulin injections. The tuberculin syringe can be used for any of the 3 types of common injections (intra-muscular or subcutaneous). The BD Integra™ I mL Syringe has a permanently attached needle. The BD Integra 1 mL Symge contains a tool used to cut through the needle to become retracted inside the plunger rod of the syringe after use. After activation the needle is fully contained inside the syringe guartal needle sticks during normal handling and disposal of the used needle syringe combination.

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K182274 510(K) SUMMARY

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PERFORMANCE DATA

The descriptive characteristics of the Orbit Subretinal Delivery System are well-defined and adequate to ensure equivalence to the predicate devices. Additionally, verification and validation testing of the Orbit Subretinal Delivery System represents a comprehensive evaluation for the suitability for use.

The following tests were successfully performed with the device components to establish substantial equivalence of the Subretinal Delivery System to the predicate and reference devices:

Biocompatibility testing in accordance with ISO 10993-01 including . Cytotoxicity (per ISO10993-5 and USP<87>), Sensitization (per ISO10993-10), Irritation, intracutaneous (per ISO10993-10), Irritation, primary eye (per ISO10993-10) and Systemic toxicity (per ISO10993-11).
Sterilization conditions were validated on the Injection Cannula Set and ● Tubing Set in accordance with ANSI/AAMI/ISO 11137-2:2013 to provide a Sterility Assurance Level of 10-6, and with ISO 11135:2014 for the syringe set. EO and ECH residuals testing was also performed with the syringe set. Testing demonstrated product performance met all prior established acceptance criteria.
Cleaning and disinfection validation was performed per FDA Guidance . "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling," and confirmed that the Third Arm Kit meets the established cleaning and disinfection requirements.
Packaging qualification was performed as part of the transportation studies to ● demonstrate that whole package physical integrity requirements and seal integrity requirements for the Subretinal Access Kit packaging were met.
Real-time shelf life testing was conducted as part of the transportation and ● design verification test program for the sterile device to establish a 29 month expiration date for the Subretinal Access Kit.
Post-distribution performance testing of the Subretinal Access Kit Testing included: .
- Syringe Set testing included visual inspection of the device as well as package integrity testing.
- Tubing Set was tested for leak pressure, tensile strength, dimensional integrity.
- Subretinal Iniection Cannula set was tested for flexural stiffness, flow rate. dimensional integrity, assembly tensile strength, and leak pressure

All tests passed pre-established test criterial and demonstrate that the Subretinal Access Kit performance is maintained following distribution.

Simulated use evaluation of the Subretinal Delivery Device was designed to confirm the . injection of saline forming a subretinal bleb. The injections were performed in a porcine model in eight (8) procedures with injection volumes of 50μl, 100μl, and 300μl.
Functionality of the Third Arm Kit was also tested to verify stability to the injection . cannula upon simulated operation during use, verification of the dose clip delivery accuracy as well as the durability of the device components. All tests passed.

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CONCLUSION

The Orbit Subretinal Delivery System meets all product design requirements and applicable standards. The device shares the same intended use, key technological characteristics as the predicate device and serves the same physiological purpose as a reference device. Therefore, the device has been shown to be substantially equivalent to the predicate devices

Regulation Number and Section

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).