(144 days)
Not Found
No
The device description and performance studies focus on the mechanical action of the solution and its preservative properties, with no mention of AI or ML.
No.
The device description and intended use clearly state that the primary mechanism of action is mechanical irrigation to loosen and remove debris and foreign materials from wounds. While it contains povidone iodine, its role is described as a preservative for the solution, not as the active therapeutic agent for the wound itself. The device functions as an irrigation system for wound debridement, which is a supportive rather than a direct therapeutic action on the wound's healing process.
No
The device is an irrigation system used to mechanically loosen and remove debris from wounds, not to diagnose a condition.
No
The device description clearly states it is a "terminally sterilized 450 mL aqueous solution" and includes a "bottle of Surgiphor™ solution," indicating it is a physical product containing a liquid, not solely software.
Based on the provided information, the BD Surgiphor™ Antimicrobial Irrigation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds." This describes a physical action on a wound, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a solution for "irrigation and debridement of wounds." This is a treatment or cleaning process, not a diagnostic test. The povidone iodine is described as a preservative for the solution itself, not as a reagent used to detect something in a patient sample.
- Lack of IVD Characteristics: There is no mention of analyzing a sample (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's condition.
IVDs are devices intended for use in vitro for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The BD Surgiphor™ system does not fit this description.
N/A
Intended Use / Indications for Use
BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds.
Product codes (comma separated list FDA assigned to the subject device)
FQH; FRO
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wounds
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
The changes do not impact the safety or effectiveness of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
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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3
510(k) SUMMARY
| Preparation Date: | October 14, 2022 |
|---|---|
| 510(k) Number: | K221504 |
| Applicant: | Becton, Dickinson and Company |
| 75 N Fairway Dr | |
| Vernon Hills, IL 60061 | |
| Contact Person: | Shelley Wilcox |
| Staff 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 System |
| Product 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:
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.
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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| Comparison
Feature | Subject Device:
BD Surgiphor™ Antimicrobial Irrigation System | Predicate Device:
BD Surgiphor™ Antimicrobial Irrigation System |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) Number | K221504 | K213616 |
| Product Code | FQH, Jet Lavage
FRO, Dressing, Wound, Drug | FQH, Jet Lavage
FRO, Dressing, Wound, Drug |
| Product
Classification | Class II (21 CFR 880.5475)
Unclassified (Pre-Amendments) | Class II (21 CFR 880.5475)
Unclassified (Pre-Amendments) |
| Device
Description | BD Surgiphor™ Antimicrobial Irrigation System is an antimicrobial
irrigation system containing 0.5% povidone iodine (PVP-I) in phosphate-
buffered saline, potassium iodide and Vitamin E TPGS. PVP-I acts as a
preservative to help inhibit microbial growth in the irrigation solution. | BD Surgiphor™ Antimicrobial Irrigation System is a system of two sterile
irrigation solutions. BD Surgiphor™ solution (0.5% povidone iodine (PVP-I
in phosphate-buffered saline, potassium iodide and Vitamin E TPGS) is used
to mechanically loosen and remove wound debris and BD SurgiRinse™
solution (0.9% saline) is used to rinse wounds. PVP-I acts as a preservative
help 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 For
Use | BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically
loosen and remove debris, and foreign materials, including microorganisms,
from wounds. | BD Surgiphor™ Antimicrobial Irrigation System is intended to mechanically
loosen and remove debris, and foreign materials, including microorganisms,
from wounds. |
| Type of Use | Prescription use only | Prescription use only |
| Mechanism of
Action | 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 in
0.9% saline) | 1 bottle of Surgiphor solution (0.5% povidone iodine plus vitamin E TPGS in
0.9% saline)
1 bottle of SurgiRinse solution (sterile saline, USP) |
| Solution
Antimicrobial
Preservative | 0.5% povidone iodine | 0.5% povidone iodine |
| How Supplied | 1 – 450 mL Surgiphor solution (0.5% povidone iodine plus vitamin E TPGS
in 0.9% saline); pH 4.6 – 7.0;
Packed within a PETG tray heat-sealed with a Tyvek® cover, and sterilized
by gamma irradiation to achieve a SAL of 10-6. IFU are included with the
system. | 1 – 450 mL bottle of Surgiphor solution (0.5% povidone iodine plus vitamin
E 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 sterilized
by gamma irradiation to achieve a SAL of 10-6. IFU are included with the
system. |
| Storage
Conditions | 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 user
squeezes the bottle to dispense the solution onto the wound. | Polycarbonate cap with a spike threads onto a polypropylene bottle. The user
squeezes the bottle to dispense the solution onto the wound. |
Table 1: Comparison of Subject Device and Predicate Device
6
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.