(128 days)
No
The device description and performance studies focus on the chemical and mechanical properties of the irrigation solutions, with no mention of AI or ML.
Yes
The device is described as an "Antimicrobial Irrigation System" intended to "mechanically loosen and remove debris, and foreign materials, including microorganisms, from wounds," which is a therapeutic action.
No
The device is intended to mechanically loosen and remove debris and foreign materials from wounds, which is a treatment action, not a diagnostic one.
No
The device description clearly states it is a "2-step system of aqueous solutions for irrigation and debridement of wounds" and mentions bottles of solutions. This indicates a physical product, not software.
Based on the provided information, the BD Surgiphor™ Antimicrobial Irrigation System is not an In Vitro Diagnostic (IVD) device.
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 description details a system of solutions used for irrigation and debridement of wounds. This is a therapeutic or procedural action, not a diagnostic test.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (like blood, tissue, or fluid) to provide information about a patient's health status or to diagnose a disease.
- Performance Studies: The performance studies focus on aspects like antimicrobial effectiveness of the solution as a preservative, biocompatibility, fluid pressure, wound healing, sterilization, packaging, and stability. These are relevant to a device used directly on a wound, not a diagnostic test.
IVD devices are used to examine 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 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.
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
Not Found
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 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.
The following tests were submitted under K202071 and remain valid for the subject device:
- Preservative Antimicrobial Effectiveness ● o USP Antimicrobial Effectiveness Testing
- . Endotoxins and Pyrogens o USP Bacterial Endotoxins Test o USP Pyrogen Test (USP Rabbit Test) o USP Medical Devices- Bacterial Endotoxin and Pyrogen Tests
- Biocompatibility ● o ISO 10993-1 Biological Evaluation of Medical Devices
- 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® o ANSI/AAMI/ISO 11137:2006/ (R) 2015 & A1:2013 & A2:2019. Sterilization of Health Care Products - Radiation - Part1: Requirements for development, validation and routine control of a sterilization process for medical devices o ANSI/AAMI/ISO 11137-1:2018/: Sterilization of Health Care Products - Microbiological methods - Part 1: Determination of the population of microorganisms on product o ANSI/AAMI/ISO 11137-2:2019/: Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process o ANSI/AAMI/ISO 11137-2:2013/ (R) 2019, Sterilization of Health Care Products - Radiation - Part 2: Establishing the sterilization dose. o (AAMI) ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing
- . Packaging and Shelf-Life o ISO 11607 Packaging for Terminally Sterilized Medical Devices o ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices o ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test) o ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- Stability Testing ● o ICH Q1A(R2) Stability Testing of New Drug Substances and Products o USP Antimicrobial Effectiveness Testing o Free Iodine Determination o % Available Iodine Determination o Osmolality Determination o USP pH Determination
- Biocompatibility ● o ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
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.
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: 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
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 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
Submission Number (if known)
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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3
510(k) SUMMARY
| Preparation Date: | 22 MAR 2021 |
|---|---|
| 510(k) Number: | K213616 |
| Applicant: | BD |
| 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 |
| Primary Predicate Device: | Irrisept® Antimicrobial Wound Lavage Product |
| System Product Code: FQH (Jet Lavage); Class II | |
| (21 CFR 880.5475) | |
| Product Code FRO (Dressing, Wound, | |
| Drug); Unclassified (pre-amendment) | |
| Applicant: Irrimax Corporation | |
| K210536 | |
| Secondary Predicate Device: | Surgiphor™ Wound Irrigation System |
| Product Code: FQH (Jet Lavage); Class II | |
| (21 CFR 880.5475) | |
| Applicant: Orthophor LLC | |
| K202071 | |
| Reference Device: | Atteris Antimicrobial Skin and Wound Cleanser |
| Product Code: FRO (Dressing, Wound, | |
| Drug); Unclassified (pre-amendment) | |
| Applicant: Rochal Industries, LLC | |
| K160192 |
4
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.
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.
5
| Comparison of Technological Characteristics | ||||
|---|---|---|---|---|
| Comparison Feature | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Reference Device |
| BD Surgiphor™ Antimicrobial | ||||
| Irrigation System | Irrisept® Antimicrobial | |||
| Wound Lavage | Surgiphor™ Wound Irrigation | |||
| System | Atteris Antimicrobial Skin | |||
| & Wound Cleanser | ||||
| 510(K) Number | TBD | K210536 | K202071 | K160192 |
| Product Code | FQH, Jet Lavage | |||
| FRO, Dressing, Wound, Drug | FQH, Jet Lavage | |||
| FRO, 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 cleansing | |||
| and removal of wound debris | Intended for wound cleansing | |||
| and removal of wound debris | 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. | Irrisept® Antimicrobial Wound | |||
| Lavage is intended for | ||||
| mechanical cleansing and | ||||
| removal of debris, dirt and | ||||
| foreign materials, including | ||||
| microorganisms from wounds. | The Surgiphor™ Wound | |||
| Irrigation System is a wound | ||||
| cleansing delivery system | ||||
| intended to loosen and remove | ||||
| wound debris. | (Rx Use) Atteris Antimicrobial | |||
| Skin & Wound Cleanser is | ||||
| intended for mechanical | ||||
| cleansing and removal of debris, | ||||
| dirt and foreign materials, | ||||
| including microorganisms from | ||||
| wounds such as stage I-IV | ||||
| pressure ulcers, diabetic foot | ||||
| ulcers, post-surgical wounds, first | ||||
| and second-degree burns, grafted | ||||
| and donor sites. |
(OTC Use) Atteris Antimicrobial
Skin & Wound Cleanser is
intended for physical cleaning
and removal of dirt and debris,
from skin scrapes, cuts,
lacerations, minor irritations, exit
sites 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™ Antimicrobial
Irrigation System | Irrisept® Antimicrobial
Wound Lavage | Surgiphor™ Wound Irrigation
System | Atteris Antimicrobial Skin
& Wound Cleanser |
| Mechanism Of Action | The mechanical action of fluid
across the wound removes wound
debris, including
microorganisms.
The change in the indications 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 of the fluid
pressure. | The mechanical action of fluid
across the wound removes wound
debris. | The mechanical action of fluid
across the wound removes wound
debris. | The mechanical action of fluid
across the wound removes wound
debris. |
| Solution | 1 bottle of Surgiphor Solution
0.5% povidone iodine plus
vitamin E TPGS in 0.9% saline,
pH 4.6 – 7.0
1 bottle of sterile saline, USP,
pH 4.0 – 7.0 | 0.05% chlorhexidine gluconate in
99.95% sterile water for
irrigation, USP | 1 bottle of Surgiphor Solution
0.5% povidone iodine plus
vitamin E TPGS in 0.9% saline,
USP, pH 4.6 – 6.4
1 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] |
| Solution
Antimicrobial
Preservative | 0.5% Povidone Iodine | 0.05% Chlorhexidine Gluconate | 0.5% Povidone Iodine | Polyaminopropyl Biguanide
[PHMB] |
| How Supplied | 1 – 450 mL bottle of Surgiphor
Solution 0.5% povidone iodine
plus vitamin E TPGS in 0.9%
saline, USP; 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. | Provided for single use. A 450
mL bottle of Irrisept is double
wrapped in CSR and sealed
within an outer Tyvek® pouch.
The bottle exterior, CSR wraps,
and applicator are sterilized by
EO gas. The bottle contains
aseptically processed Irrisept
solution. | 1 – 450 mL bottle of Surgiphor
Solution 0.5% povidone iodine
plus vitamin E TPGS in 0.9%
saline, USP; 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. | Provided Non-Sterile In 8 Fluid
Ounce Bottle with Sprayer. |
| Comparison of Technological Characteristics | | | | |
| Comparison Feature | Proposed Device | Primary Predicate Device | Secondary Predicate Device | Reference Device |
| | BD Surgiphor™ Antimicrobial
Irrigation System | Irrisept® Antimicrobial
Wound Lavage | Surgiphor™ Wound Irrigation
System | Atteris Antimicrobial Skin
& Wound Cleanser |
| Applicator | Polycarbonate cap with a spike
threads onto a polypropylene
bottle. The user squeezes the
bottle to dispense the solution
onto the wound. | Multiport applicator that threads
onto the Irrisept bottle. | Polycarbonate cap with a spike
threads onto a polypropylene
bottle. The user squeezes the
bottle to dispense the solution
onto the wound. | Sprayer Attachment |
| Sterilization | The BD Surgiphor™
Antimicrobial Irrigation System
is provided terminally sterile to a
SAL of 10-6 by gamma
irradiation. The system is
validated in accordance with
ANSI/AAMI/ISO TIR13004:
Sterilization of health care
products- Radiation -
Substantiation of a selected
sterilization dose: Method
VDmaxSD | Bottle exterior, CSR wraps, and
outer packaging conforms to ISO
11135-7 for EO sterilization and
ISO 10993-7 for EO residuals
whereas the solution is
aseptically processed. | The Surgiphor Sterile Wound
Irrigation System is provided
terminally sterile to a SAL of
10-6 by gamma irradiation. The
system is validated in accordance
with ANSI/AAMI/ISO TIR13004:
Sterilization of health care
products- Radiation -
Substantiation of a selected
sterilization dose: Method
VDmaxSD | Provided non-sterile |
| Biocompatibility | Biocompatible per ISO 10993-1
Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk management
process, Annex A (informative)
Biological evaluation tests as a
surface device (breached or
compromised) with limited
contact (≤ 24 hours).
Added Teflon coating to the mold
to manufacture the cap. The
components of the mold that are
Teflon coated do not come into
contact with the fluid-contacting
portions of the cap. | Biocompatible per ISO 10993
testing for a surface device with
breached or compromised surface
contact and a limited duration (≤
24 hours) | Biocompatible per ISO 10993-1
Biological evaluation of medical
devices - Part 1: Evaluation and
testing within a risk management
process, Annex A (informative)
Biological evaluation tests as a
surface device (breached or
compromised) with limited
contact (≤ 24 hours).
No Teflon Coating on the mold to
manufacture the cap. | Biocompatible per ISO 10993
testing |
| Preservative
Effectiveness over
Shelf-Life | Demonstrated per USP
testing. | Demonstrated per USP
testing. | Demonstrated per USP
testing. | Demonstrated per USP
testing. |
| Storage Temperature | Store at room temperature. Avoid
freezing and excessive heat
above 40°C (104°F) | 10°C to 30°C | 10°C to 30°C | Unknown |
6
7
8
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 Antimicrobial Effectiveness Testing
- . Endotoxins and Pyrogens
- o USP Bacterial Endotoxins Test
- 0 USP Pyrogen Test (USP Rabbit Test)
- o USP 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
9
- Stability Testing ●
- ICH Q1A(R2) Stability Testing of New Drug Substances and Products O
- USP Antimicrobial Effectiveness Testing O
- Free Iodine Determination o
- % Available Iodine Determination o
- o Osmolality Determination
- USP 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.