BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

Device Description

The BD Surgiphor™ Antimicrobial Irrigation System is a 2-step system of aqueous solutions for irrigation and debridement of wounds. The 2-step process includes one bottle of Surgiphor™ Solution (0.5% Povidone Iodine) which is used first to loosen wound debris, and one bottle of SurgiRinse™ Solution (saline solution, USP 99.95%) which is used second to rinse the loosened debris from the wound. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the removal of debris, and foreign materials, including microorganisms, from wounds. The BD Surgiphor™ Antimicrobial Irrigation System is provided as a two-part terminally sterilized system with 450 mL of each solution. The povidone in the Surgiphor™ Solution serves as a preservative to ensure that no unwanted microbial growth occurs in the solution after the bottle is open.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "BD Surgiphor Antimicrobial Irrigation System." It focuses on demonstrating substantial equivalence to predicate devices, particularly regarding the addition of "microorganisms" to the device's indications for use.

Based on the provided text, the device is a medical irrigation system, not an AI/ML device. Therefore, the questions about acceptance criteria, study design, and performance related to AI/ML (e.g., sample size, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets) are not applicable to this submission.

The document primarily addresses the substantial equivalence of a physical medical device. The "performance testing" section refers to standard medical device testing (e.g., sterility, biocompatibility, packaging, stability, fluid pressure testing for mechanical action), not AI/ML model performance.

Here's a summary of what is provided regarding acceptance criteria and performance, as applicable to this medical device:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria for performance in the way one would for an AI/ML device (e.g., accuracy, sensitivity, specificity thresholds). Instead, it states that "Substantial equivalence has been confirmed through performance testing." The performance testing described is primarily focused on demonstrating the physical and chemical properties and safety of the device, rather than a diagnostic or predictive performance metric.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Preservative Antimicrobial Effectiveness	Compliance with USP <51>	Demonstrated per USP <51> testing. (Implies compliance)
Endotoxins and Pyrogens	Compliance with USP <85>, <151>, <161>	Demonstrated per specified USP tests. (Implies compliance)
Biocompatibility	Compliance with ISO 10993-1	Biocompatible per ISO 10993-1. (Implies compliance)
Fluid Pressure Testing	Adequate pressure for mechanical action to remove debris (implied)	Demonstrated by testing provided in this 510(k). (Implies adequate performance for its intended mechanical action)
Sterilization	SAL of 10^-6, compliance with ISO standards	Provided terminally sterile to a SAL of 10^-6 by gamma irradiation, validated in accordance with specified ANSI/AAMI/ISO standards. (Implies compliance)
Packaging and Shelf-Life	Compliance with ISO 11607, ASTM F1980, F2096, D4169	Demonstrated compliance with specified ISO and ASTM standards for packaging and accelerated aging. (Implies integrity and stability over shelf-life)
Stability Testing	Compliance with ICH Q1A(R2), USP <51>, and specific chemical assays	Demonstrated compliance with specified standards and successful determination of Free Iodine, % Available Iodine, Osmolality, and pH (Implies chemical and physical stability over time).

2. Sample size used for the test set and the data provenance:

Not applicable for an AI/ML context. The tests are for the physical device, not an algorithm processing data.

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. Ground truth in the context of an AI/ML study does not apply to this physical device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. This relates to expert review of data for AI/ML model ground truth.

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 study type is for evaluating AI assistance in diagnostic tasks.

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

Not applicable. There is no algorithm being evaluated in this submission.

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

Not applicable in the AI/ML sense. The "ground truth" for this device's effectiveness relies on the mechanical action of fluid physically removing debris, which is demonstrated through fluid pressure testing and comparison to predicate devices, rather than a diagnostic 'truth'. The claim for "microorganism removal" is based on its mechanical action, not a specific antimicrobial kill claim.

8. The sample size for the training set:

Not applicable. There is no training set for an AI/ML model.

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

Not applicable. There is no training set for an AI/ML model.

In summary, the provided document is a 510(k) summary for a physical medical device, not an AI/ML device. Therefore, questions 1 (in the AI/ML context), 2, 3, 4, 5, 6, 7 (in the AI/ML context), 8, and 9 are not addressed in the text as they pertain to AI/ML model development and validation. The acceptance criteria and performance discussions are framed within the context of a medical device's physical, chemical, and sterility properties, and its intended mechanical action, demonstrating substantial equivalence to legally marketed predicates.

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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

March 23, 2022

Becton, Dickinson and Company Shellev Wilcox Staff Regulatory Affairs Specialist 75 N Fairway Dr Vernon Hills, Illinois 60061

Re: K213616

Trade/Device Name: BD Surgiphor Antimicrobial Irrigation System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FOH, FRO Dated: February 15, 2022 Received: February 16, 2022

Dear Shelley Wilcox:

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

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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,

Julie Morabito Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K213616

Device Name

BD Surqiphor™ Antimicrobial Irrigation System (910100)

Indications for Use (Describe)

BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Preparation Date:	22 MAR 2021
510(k) Number:	K213616
Applicant:	BD75 N Fairway DrVernon Hills, IL 60061
Contact Person:	Shelley WilcoxStaff Specialist, Regulatory AffairsTel: (303) 324-3816
Device Trade Name:	BD Surgiphor™ Antimicrobial Irrigation System
Classification Name:	Jet Lavage
Device Classification:	Class II (21 CFR 880.5475)Unclassified (Pre-amendment)
Product Code:	FQH; FRO
Primary Predicate Device:	Irrisept® Antimicrobial Wound Lavage ProductSystem Product Code: FQH (Jet Lavage); Class II(21 CFR 880.5475)Product Code FRO (Dressing, Wound,Drug); Unclassified (pre-amendment)Applicant: Irrimax CorporationK210536
Secondary Predicate Device:	Surgiphor™ Wound Irrigation SystemProduct Code: FQH (Jet Lavage); Class II(21 CFR 880.5475)Applicant: Orthophor LLCK202071
Reference Device:	Atteris Antimicrobial Skin and Wound CleanserProduct Code: FRO (Dressing, Wound,Drug); Unclassified (pre-amendment)Applicant: Rochal Industries, LLCK160192

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Device Description:

Indications for Use:

BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.

Comparison of Technological Characteristics:

The subject BD Surgiphor™ Antimicrobial Irrigation System is substantially equivalent to its secondary predicate, predecessor Surgiphor Wound Irrigation System (K202071), primary predicate Irrisept® Antimicrobial Wound Lavage (K210536) and reference device, Atteris Antimicrobial Skin and Wound Cleanser (K160192).

The Surgiphor solution comprises 0.5% povidone iodine in sterile saline while the Irrisept solution comprises 0.05% chlorhexidine gluconate and the Atteris solution, polyaminopropyl biguanide (PHMB) in purified water. The composition of all three solutions acts as a preservative to inhibit microbial growth in the respective solutions.

The mechanism of action is the same between the proposed and the predicates, specifically, the mechanical action of fluid across the wound removes wound debris, including microorganisms. The mechanism of action is defined by the fluid pressure of the solution, dispensed upon a wound. which is demonstrated by testing provided in this 510(k).

The BD Surgiphor™ Antimicrobial Irrigation System is unchanged from the legally marketed predicate Surgiphor™ Wound Irrigation System (K202071) in its intended use, performance, and technological characteristics except as noted in subsequent comparison of technological characteristics table. The removal of wound debris and foreign materials, including microorganisms, is consistent with the primary predicate Irrisept® Antimicrobial Wound Lavage (K210536) and reference predicate device Atteris Antimicrobial Skin & Wound Cleanser (K160192). All three predicate devices have intended use and apply a solution to the wound for removal of wound debris and foreign materials, including microorganisms.

This 510(k) is to specify the removal of microorganisms through mechanical cleansing action within the indications for use statement of the BD Surgiphor™ Antimicrobial Irrigation System consistent with predicates Irrisept Antimicrobial Wound Lavage and the Atteris Antimicrobial Skin & Wound Cleanser.

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Comparison of Technological Characteristics
Comparison Feature	Proposed Device	Primary Predicate Device	Secondary Predicate Device	Reference Device
	BD Surgiphor™ AntimicrobialIrrigation System	Irrisept® AntimicrobialWound Lavage	Surgiphor™ Wound IrrigationSystem	Atteris Antimicrobial Skin& Wound Cleanser
510(K) Number	TBD	K210536	K202071	K160192
Product Code	FQH, Jet LavageFRO, Dressing, Wound, Drug	FQH, Jet LavageFRO, Dressing, Wound, Drug	FQH, Jet Lavage	FRO, Dressing, Wound, Drug
Product Classification	Class II (21 CFR 880.5475)Unclassified (Pre-Amendment)	Class II (21 CFR 880.5475)Unclassified (Pre-Amendment)	Class II (21 CFR 880.5475)	Unclassified (Pre-Amendment)
Intended Use	Intended for wound cleansingand removal of wound debris	Intended for wound cleansingand removal of wound debris	Intended for wound cleansingand removal of wound debris	Intended for wound cleansingand removal of wound debris
Indications For Use	BD Surgiphor™ AntimicrobialIrrigation System is intended tomechanically loosen and removedebris, and foreign materials,including microorganisms, fromwounds.	Irrisept® Antimicrobial WoundLavage is intended formechanical cleansing andremoval of debris, dirt andforeign materials, includingmicroorganisms from wounds.	The Surgiphor™ WoundIrrigation System is a woundcleansing delivery systemintended to loosen and removewound debris.	(Rx Use) Atteris AntimicrobialSkin & Wound Cleanser isintended for mechanicalcleansing and removal of debris,dirt and foreign materials,including microorganisms fromwounds such as stage I-IVpressure ulcers, diabetic footulcers, post-surgical wounds, firstand second-degree burns, graftedand donor sites.(OTC Use) Atteris AntimicrobialSkin & Wound Cleanser isintended for physical cleaningand removal of dirt and debris,from skin scrapes, cuts,lacerations, minor irritations, exitsites and unbroken skin.
Type Of Use	Prescription use only	Prescription use only	Prescription use only	Both prescription use and over-the-counter use
Comparison of Technological Characteristics
Comparison Feature	Proposed Device	Primary Predicate Device	Secondary Predicate Device	Reference Device
	BD Surgiphor™ AntimicrobialIrrigation System	Irrisept® AntimicrobialWound Lavage	Surgiphor™ Wound IrrigationSystem	Atteris Antimicrobial Skin& Wound Cleanser
Mechanism Of Action	The mechanical action of fluidacross the wound removes wounddebris, includingmicroorganisms.The change in the indications foruse to include removal ofmicroorganisms as a typeof wound debris does not changethe intended use of the deviceand does not raise newsafety and effectivenessconcerns. Substantial equivalencehas been confirmed throughperformance testing of the fluidpressure.	The mechanical action of fluidacross the wound removes wounddebris.	The mechanical action of fluidacross the wound removes wounddebris.	The mechanical action of fluidacross the wound removes wounddebris.
Solution	1 bottle of Surgiphor Solution0.5% povidone iodine plusvitamin E TPGS in 0.9% saline,pH 4.6 – 7.01 bottle of sterile saline, USP,pH 4.0 – 7.0	0.05% chlorhexidine gluconate in99.95% sterile water forirrigation, USP	1 bottle of Surgiphor Solution0.5% povidone iodine plusvitamin E TPGS in 0.9% saline,USP, pH 4.6 – 6.41 bottle of sterile saline, USP,pH 4.0 – 6.5	Purified water, poloxamer 407,sodium chloride,ethylhexylglycerin,hypromellose, octane-1,2-diol,polyaminopropyl biguanide[PHMB]
SolutionAntimicrobialPreservative	0.5% Povidone Iodine	0.05% Chlorhexidine Gluconate	0.5% Povidone Iodine	Polyaminopropyl Biguanide[PHMB]
How Supplied	1 – 450 mL bottle of SurgiphorSolution 0.5% povidone iodineplus vitamin E TPGS in 0.9%saline, USP; 1 – 450 mL bottle ofsterile saline, USP; packed withina PETG tray heat-sealed with aTyvek® cover and sterilized bygamma irradiation to achieve aSAL of 10-6. IFU are includedwith the system.	Provided for single use. A 450mL bottle of Irrisept is doublewrapped in CSR and sealedwithin an outer Tyvek® pouch.The bottle exterior, CSR wraps,and applicator are sterilized byEO gas. The bottle containsaseptically processed Irriseptsolution.	1 – 450 mL bottle of SurgiphorSolution 0.5% povidone iodineplus vitamin E TPGS in 0.9%saline, USP; 1 – 450 mL bottle ofsterile saline, USP; packed withina PETG tray heat-sealed with aTyvek® cover and sterilized bygamma irradiation to achieve aSAL of 10-6. IFU are includedwith the system.	Provided Non-Sterile In 8 FluidOunce Bottle with Sprayer.
Comparison of Technological Characteristics
Comparison Feature	Proposed Device	Primary Predicate Device	Secondary Predicate Device	Reference Device
	BD Surgiphor™ AntimicrobialIrrigation System	Irrisept® AntimicrobialWound Lavage	Surgiphor™ Wound IrrigationSystem	Atteris Antimicrobial Skin& Wound Cleanser
Applicator	Polycarbonate cap with a spikethreads onto a polypropylenebottle. The user squeezes thebottle to dispense the solutiononto the wound.	Multiport applicator that threadsonto the Irrisept bottle.	Polycarbonate cap with a spikethreads onto a polypropylenebottle. The user squeezes thebottle to dispense the solutiononto the wound.	Sprayer Attachment
Sterilization	The BD Surgiphor™Antimicrobial Irrigation Systemis provided terminally sterile to aSAL of 10-6 by gammairradiation. The system isvalidated in accordance withANSI/AAMI/ISO TIR13004:Sterilization of health careproducts- Radiation -Substantiation of a selectedsterilization dose: MethodVDmaxSD	Bottle exterior, CSR wraps, andouter packaging conforms to ISO11135-7 for EO sterilization andISO 10993-7 for EO residualswhereas the solution isaseptically processed.	The Surgiphor Sterile WoundIrrigation System is providedterminally sterile to a SAL of10-6 by gamma irradiation. Thesystem is validated in accordancewith ANSI/AAMI/ISO TIR13004:Sterilization of health careproducts- Radiation -Substantiation of a selectedsterilization dose: MethodVDmaxSD	Provided non-sterile
Biocompatibility	Biocompatible per ISO 10993-1Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess, Annex A (informative)Biological evaluation tests as asurface device (breached orcompromised) with limitedcontact (≤ 24 hours).Added Teflon coating to the moldto manufacture the cap. Thecomponents of the mold that areTeflon coated do not come intocontact with the fluid-contactingportions of the cap.	Biocompatible per ISO 10993testing for a surface device withbreached or compromised surfacecontact and a limited duration (≤24 hours)	Biocompatible per ISO 10993-1Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess, Annex A (informative)Biological evaluation tests as asurface device (breached orcompromised) with limitedcontact (≤ 24 hours).No Teflon Coating on the mold tomanufacture the cap.	Biocompatible per ISO 10993testing
PreservativeEffectiveness overShelf-Life	Demonstrated per USP <51>testing.	Demonstrated per USP <51>testing.	Demonstrated per USP <51>testing.	Demonstrated per USP <51>testing.
Storage Temperature	Store at room temperature. Avoidfreezing and excessive heatabove 40°C (104°F)	10°C to 30°C	10°C to 30°C	Unknown

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Performance Testing

There are no technological differences between the two versions of the Surgiphor System. The change to the BD labeled indication for use to include removal of "microorganisms" as a type of wound debris does not change the intended use of the device and does not raise new safety and effectiveness concerns. Substantial equivalence has been confirmed through performance testing as summarized below.

The following tests were submitted under K202071 and remain valid for the subject device:

Preservative Antimicrobial Effectiveness ●
- o USP <51> Antimicrobial Effectiveness Testing
. Endotoxins and Pyrogens
- o USP <85> Bacterial Endotoxins Test
- 0 USP <151> Pyrogen Test (USP Rabbit Test)
- o USP <161> Medical Devices- Bacterial Endotoxin and Pyrogen Tests
Biocompatibility ●
- ISO 10993-1 Biological Evaluation of Medical Devices o
Fluid Pressure Testing ●
Nonclinical Wound Healing Study ●

The following tests were conducted to support the transfer of the Surgiphor System to BD:

Sterilization ●
- o ANSI/AAMI/ISO TIR13004:2013, Sterilization of Health Care Products -Radiation - Substantiation of a Selected Sterilization Dose: Method VDmax®
- ANSI/AAMI/ISO 11137:2006/ (R) 2015 & A1:2013 & A2:2019. Sterilization O of Health Care Products - Radiation - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-1:2018/: Sterilization of Health Care Products - O Microbiological methods - Part 1: Determination of the population of microorganisms on product
- ANSI/AAMI/ISO 11137-2:2019/: Sterilization of medical devices - O Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process
- ANSI/AAMI/ISO 11137-2:2013/ (R) 2019, Sterilization of Health Care O Products - Radiation - Part 2: Establishing the sterilization dose.
- (AAMI) ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, O Routine Monitoring, and Alternatives to Batch Testing
. Packaging and Shelf-Life
- ISO 11607 Packaging for Terminally Sterilized Medical Devices O
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier O Systems for Medical Devices
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in O Packaging by Internal Pressurization (Bubble Test)
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping O Containers and Systems

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Stability Testing ●
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products O
- USP <51> Antimicrobial Effectiveness Testing O
- Free Iodine Determination o
- % Available Iodine Determination o
- o Osmolality Determination
- USP <791> pH Determination o
Biocompatibility ●
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: o Evaluation and testing within a risk management process

Substantial Equivalence Conclusion

The performance testing conducted demonstrates that the subject BD Surgiphor™ Antimicrobial Irrigation System is substantially equivalent to the primary predicate, Irrisept device and the secondary predicate, Surgiphor Wound Irrigation System in intended use and technological characteristics and this premarket notification supports the addition of "microorganisms" as a type of wound debris removed by the device in the labeled indications for use.

Regulation Number and Section

§ 880.5475 Jet lavage.

(a)
Identification. A jet lavage is a device used to clean a wound by a pulsatile jet of sterile fluid. The device consists of the pulsing head, tubing to connect to a container of sterile fluid, and a means of propelling the fluid through the tubing, such as an electric roller pump.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.