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

Device Description

The subject BD Surgiphor™ Antimicrobial Irrigation System is a terminally sterilized 450 mL aqueous solution for irrigation and debridement of wounds. The device includes one bottle of Surgiphor™ solution (0.5% Povidone Iodine) which is used to loosen and remove wound debris. The mechanical action of fluid moving across the wound provides the mechanism of action and aids in the loosening and removal of debris, and foreign materials, including microorganisms, from wounds. The povidone iodine 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 a medical device called the "BD Surgiphor™ Antimicrobial Irrigation System." This submission is based on demonstrating substantial equivalence to a previously cleared predicate device (K213616).

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance:

The core of this 510(k) submission is to demonstrate that a modified device is substantially equivalent to a predicate device, not to establish new performance criteria for a novel device. Therefore, the "acceptance criteria" here are primarily tied to demonstrating that the changes made do not negatively impact the safety or effectiveness of the device compared to the predicate.

The main change in the subject device (K221504) from its predicate (K213616) is the removal of the SurgiRinse™ solution bottle. The device still includes one bottle of Surgiphor™ solution. The manufacturer asserts that the fundamental "mechanism of action" (mechanical loosening and removal of debris and foreign materials, including microorganisms, from wounds through fluid pressure) remains unchanged. The povidone iodine in the Surgiphor™ solution continues to act as a preservative.

Given this context, the acceptance criteria are implicitly met by demonstrating that the modified device performs comparably to the predicate device, specifically by showing that removing the rinse bottle does not introduce new safety or efficacy concerns.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) for a modified device, the "acceptance criteria" are not reported as specific performance metrics like sensitivity, specificity, or accuracy (as one might see for an AI/ML device). Instead, the acceptance criteria are met by demonstrating that the changes do not degrade performance or safety.

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance/Evidence Provided
Intended Use Equivalence	The modified device maintains the same intended use as the predicate.	"The BD Surgiphor™ Antimicrobial Irrigation System is unchanged from the legally marketed predicate BD Surgiphor™ Antimicrobial Irrigation System (K213616) in its intended use... specifically, to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds." (Page 4, Comparison of Technological Characteristics)
Mechanism of Action	The modified device operates via the same mechanism of action as the predicate.	"The mechanism of action is defined by the fluid pressure of the solution dispensed upon a wound." (Page 4, Comparison of Technological Characteristics) This is consistent with the predicate.
Solution Composition	The primary active solution (Surgiphor™) remains chemically identical to that in the predicate.	"There is no change to the solution composition from the predicate to the subject Surgiphor™ solution." (Page 4, Comparison of Technological Characteristics)
Safety	The removal of the SurgiRinse™ bottle does not introduce new safety concerns (e.g., related to sterility, packaging integrity, or material compatibility).	This is addressed through the verification and validation testing, particularly in the areas of Sterilization, Packaging and Shelf-Life, and the statement that "the change does not raise new safety and effectiveness concerns." (Page 4, "Substantial equivalence has been demonstrated through standards compliance and design verification and validation testing.")
Effectiveness	The mechanical action for debris removal is not compromised by the absence of the separate rinse bottle, as the user is still instructed to use sterile saline for rinsing (which is "readily available"). The preservative function of PVP-I is maintained.	"Users are still instructed to use sterile saline to rinse the Surgiphor™ solution immediately after irrigation." (Page 4, Device Description) The effectiveness of the Surgiphor solution itself in loosening debris is inherent to the predicate and is stated to be unchanged. The lack of change to the solution composition and mechanism of action implies no change in effectiveness for the primary function.
Compliance with Standards	The manufacturing process and device characteristics continue to conform to relevant recognized standards for medical devices.	"Substantial equivalence has been demonstrated through standards compliance and design verification and validation testing." Specific standards listed include those for Sterilization (ANSI/AAMI/ISO 11137 series, 11737-1, TIR13004) and Packaging and Shelf-Life (ISO 11607-1, ASTM F1980, F2096, D4169, F2825). (Page 6)

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

The document does not describe a "test set" in the context of an AI/ML algorithm or a clinical trial with human subjects. This 510(k) relies on design verification and validation testing and standards compliance to demonstrate substantial equivalence to a predicate device, given a minor change (removal of one component from a kit).

Therefore, there is no mention of data provenance (country of origin, retrospective/prospective) because the studies are primarily engineering and quality control tests (sterilization, packaging, shelf-life) rather than clinical performance studies on patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable to this 510(k) submission. Ground truth establishment by experts (e.g., radiologists) is typically relevant for diagnostic AI/ML devices where a clinical reference standard is needed. This device is a physical irrigation system, and its "ground truth" for substantial equivalence is derived from a combination of:

The established performance and safety of its predicate device.
Laboratory testing (sterilization, packaging) against recognized standards.
Engineering assessment that a structural change (removing a bottle) does not alter intended use or introduce new risks.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as #3. Clinical adjudication methods are not relevant for the type of testing described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable. An MRMC study is relevant for evaluating the performance of diagnostic aids, particularly AI/ML algorithms, in how they affect human reader performance. This device is an irrigation system, not a diagnostic tool, and the submission is focused on physical and chemical equivalence and safety, not on human interpretation of outputs.

6. Standalone (Algorithm Only) Performance:

This information is not applicable. This submission is for a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through:

Engineering specifications and design verification: Ensuring the physical and chemical properties of the device (solution composition, packaging, sterility) remain consistent with safe and effective operation as defined by standards.
Predicate device's established safety and effectiveness: The fundamental "truth" is that the predicate device was already deemed safe and effective for its intended use, and the current submission argues that the modified device maintains this "truth" despite the change.

8. Sample Size for the Training Set:

This information is not applicable. There is no "training set" as this device does not involve an AI/ML component.

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

This information is not applicable. Since there is no training set, there is no ground truth established for it.

In summary:

The provided FDA letter and 510(k) summary pertain to a physical medical device (an irrigation system) undergoing a minor modification. The "acceptance criteria" and "study" described are primarily related to engineering validation, quality control testing (e.g., sterility, shelf-life), and a comparison to a legally marketed predicate device to demonstrate substantial equivalence. It does not involve the types of studies (e.g., clinical trials, AI/ML performance evaluations) that would typically require the detailed information on test sets, expert readers, or ground truth methodologies for diagnostic or AI-powered devices. The crucial point of this submission is the statement: "The changes do not impact the safety or effectiveness of the subject device [compared to the predicate device]."

Summary

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October 14, 2022

BD Shelley Wilcox Staff Regulatory Affairs Specialist 75 N Fairway Dr Vernon Hills, Illinois 60061

Re: K221504

Trade/Device Name: BD Surgiphor™ Antimicrobial Irrigation System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage; Wound dressing, drug Regulatory Class: Class II; Unclassified Product Code: FQH; FRO Dated: August 30, 2022 Received: August 31, 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, Ph.D. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K221504

Device Name

BD Surgiphor TM Antimicrobial Irrigation System

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) SUMMARY

Preparation Date:	October 14, 2022
510(k) Number:	K221504
Applicant:	Becton, Dickinson and Company75 N Fairway DrVernon Hills, IL 60061
Contact Person:	Shelley WilcoxStaff Specialist, Regulatory Affairs,Tel: (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
Predicate Device:	BD Surgiphor™ Antimicrobial Irrigation SystemProduct Code: FQH (Jet Lavage), FRO (Dressing,Wound, Drug); Class II(21 CFR 880.5475)Applicant: Becton, Dickinson and Company (BD)K213616

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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 predicate, predecessor BD Surgiphor™ Antimicrobial Irrigation System (K213616).

The BD Surgiphor™ Antimicrobial Irrigation System is unchanged from the legally marketed predicate BD Surgiphor™ Antimicrobial Irrigation System (K213616) in its intended use, performance, and technological characteristics, specifically, to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds. The mechanism of action is defined by the fluid pressure of the solution dispensed upon a wound.

This 510(k) proposes to remove the bottle of SurgiRinse™ solution from the predicate two bottle system as sterile saline solutions are readily available for use. Users are still instructed to use sterile saline to rinse the Surgiphor™ solution immediately after irrigation. As such the subject BD Surgiphor™ Antimicrobial Irrigation System comprises of only one bottle of Surgiphor™ solution containing 0.5% povidone iodine (PVP-I) in phosphate-buffered saline, potassium iodide and Vitamin E TPGS. There is no change to the solution composition from the predicate to the subject Surgiphor™ solution. This difference results in a change to the packaging size and the labeling content. The packaging utilizes the same materials of construction.

The only difference between the subject and the predicate is the removal of the SurgiRinse™ solution. There is no change to the intended use of the device and the change does not raise new safety and effectiveness concerns. Substantial equivalence has been demonstrated through standards compliance and design verification and validation testing.

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ComparisonFeature	Subject Device:BD Surgiphor™ Antimicrobial Irrigation System	Predicate Device:BD Surgiphor™ Antimicrobial Irrigation System
510(K) Number	K221504	K213616
Product Code	FQH, Jet LavageFRO, Dressing, Wound, Drug	FQH, Jet LavageFRO, Dressing, Wound, Drug
ProductClassification	Class II (21 CFR 880.5475)Unclassified (Pre-Amendments)	Class II (21 CFR 880.5475)Unclassified (Pre-Amendments)
DeviceDescription	BD Surgiphor™ Antimicrobial Irrigation System is an antimicrobialirrigation system containing 0.5% povidone iodine (PVP-I) in phosphate-buffered saline, potassium iodide and Vitamin E TPGS. PVP-I acts as apreservative to help inhibit microbial growth in the irrigation solution.	BD Surgiphor™ Antimicrobial Irrigation System is a system of two sterileirrigation solutions. BD Surgiphor™ solution (0.5% povidone iodine (PVP-Iin phosphate-buffered saline, potassium iodide and Vitamin E TPGS) is usedto mechanically loosen and remove wound debris and BD SurgiRinse™solution (0.9% saline) is used to rinse wounds. PVP-I acts as a preservativehelp inhibit microbial growth in the irrigation solution.
Intended Use	Intended for wound cleansing and removal of wound debris	Intended for wound cleansing and removal of wound debris
Indications ForUse	BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanicallyloosen and remove debris, and foreign materials, including microorganisms,from wounds.	BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanicallyloosen and remove debris, and foreign materials, including microorganisms,from wounds.
Type of Use	Prescription use only	Prescription use only
Mechanism ofAction	The mechanical action of fluid across the wound removes wound debris,including microorganisms.	The mechanical action of fluid across the wound removes wound debris,including microorganisms.
Solution	1 bottle of Surgiphor solution (0.5% povidone iodine plus vitamin E TPGS in0.9% saline)	1 bottle of Surgiphor solution (0.5% povidone iodine plus vitamin E TPGS in0.9% saline)1 bottle of SurgiRinse solution (sterile saline, USP)
SolutionAntimicrobialPreservative	0.5% povidone iodine	0.5% povidone iodine
How Supplied	1 – 450 mL Surgiphor solution (0.5% povidone iodine plus vitamin E TPGSin 0.9% saline); pH 4.6 – 7.0;Packed within a PETG tray heat-sealed with a Tyvek® cover, and sterilizedby gamma irradiation to achieve a SAL of 10-6. IFU are included with thesystem.	1 – 450 mL bottle of Surgiphor solution (0.5% povidone iodine plus vitaminE TPGS in 0.9% saline); pH 4.6 – 7.0;1 – 450 mL bottle of sterile saline, USP;Packed within a PETG tray heat-sealed with a Tyvek® cover, and sterilizedby gamma irradiation to achieve a SAL of 10-6. IFU are included with thesystem.
StorageConditions	Store at room temperature. Avoid freezing or heating above 40°C (104°F).	Store at room temperature. Avoid freezing or heating above 40°C (104°F).
Applicator	Polycarbonate cap with a spike threads onto a polypropylene bottle. The usersqueezes the bottle to dispense the solution onto the wound.	Polycarbonate cap with a spike threads onto a polypropylene bottle. The usersqueezes the bottle to dispense the solution onto the wound.

Table 1: Comparison of Subject Device and Predicate Device

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The following tests were conducted to support the changes under this traditional 510(k):

Sterilization .
- ANSI/AAMI/ISO TIR13004:2015, Sterilization of Health Care Products -O Radiation - Substantiation of a Selected Sterilization Dose: Method VDmaxSD
- ANSI/AAMI/ISO 11137-1:2006/ (R) 2015 & A1:2013 & A2:2019, Sterilization of O Health Care Products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
- ANSI/AAMI/ISO 11137-2:2013/ (R) 2019, Sterilization of Health Care Products O - Radiation - Part 2: Establishing the sterilization dose
- ANSI/AAMI/ISO 11737-1:2018: Sterilization of Health Care Products -O Microbiological methods – Part 1: Determination of the population of microorganisms on product
Packaging and Shelf-Life
- ISO 11607-1, Packaging for Terminally Sterilized Medical Devices o
- ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems O for Medical Devices
- ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Packaging O by Internal Pressurization (Bubble Test)
- ASTM D4169-16, Standard Practice for Performance Testing of Shipping O Containers and Systems
- ASTM F2825-18: Standard Practice for Climatic Stressing of Packaging System O for Single Parcel Delivery

Substantial Equivalence Conclusion

The subject BD Surgiphor™ Antimicrobial Irrigation System is substantially equivalent to the previously cleared BD Surgiphor™ Antimicrobial Irrigation System (K213616) with the changes described within this submission. The changes do not impact the safety or effectiveness of the subject device.

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.