(88 days)
No
The description focuses on the chemical and mechanical properties of the solutions and the delivery system, with no mention of AI or ML.
No
The device is described as a wound cleansing delivery system intended to loosen and remove wound debris through mechanical action and serves as a preservative to prevent microbial growth in the solution. It does not treat or prevent a disease or condition, which is a characteristic of a therapeutic device.
No
The device is intended for wound cleansing and debridement, which involves loosening and removing wound debris. This is a therapeutic 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 includes bottles of solutions. This indicates a physical product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "a wound cleansing delivery system intended to loosen and remove wound debris." This describes a physical action on a wound, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details solutions used for irrigation and debridement of wounds. This is a therapeutic or cleansing action, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing a sample (blood, tissue, etc.) to diagnose a condition, identify a pathogen, or measure a biomarker.
- Performance Studies: The performance studies focus on the physical properties of the solutions, their mechanical action, biocompatibility, and effects on wound healing and irritation. These are relevant to a wound care product, not a diagnostic test.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
Product codes
FOH
Device Description
SURGIPHOR™ Wound 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™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ 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 from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. 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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
intended for use by healthcare professionals
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)
Non-clinical Testing – Bench Study Comparison:
The subject device has mechanical properties substantially equivalent to commercially available devices with the same intended uses. The following characteristics were evaluated: Device Component (SURGIPHOR™, SurgiRinse™) for pH, Osmolality, Chemical Analysis, Particulates. The subject device was also tested to show equivalent mechanical action to the predicate device, demonstrating that the pressure produced during the use of the device is sufficient to agitate, loosen and remove debris from wounds. Further testing to demonstrate the device preservative povidone is effective throughout the intended use duration of the device (24 hours after opening) was conducted following USP.
Performance Testing – Animal Study:
The SURGIPHOR™ Wound Irrigation System was evaluated in a full thickness porcine wound healing model demonstrating that the test article does not appear to inhibit normal wound healing when compared to the predicate device.
Non-Clinical Testing – Biocompatibility:
The SURGIPHOR™ Wound Irrigation System is categorized as a surface device with limited contact with breached or compromised surfaces per ISO 10993-1 2007, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and FDA's Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (June 16, 2016). The device was evaluated for the appropriate biocompatibility characteristics, as well as conducting a Toxicological Risk Assessment to evaluate the safety of the device and each of the device components.
Clinical Testing:
The SURGIPHOR™ Wound Irrigation System was evaluated in a Human Repeat Insult Patch Test with a primary endpoint assessing the irritation potential in humans. Additionally, a Human Abraded Skin Patch Test for Pyrogenicity was conducted with a primary endpoint of assessing the potential for pyrogenic response in humans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 23, 2020
Orthophor, LLC % Elizabeth O'Keeffe Director of Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway Suite 120 Woodstock, Georgia 30188
Re: K202071
Trade/Device Name: SURGIPHOR Wound Irrigation System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II Product Code: FOH Dated: July 24, 2020 Received: July 27, 2020
Dear Elizabeth O'Keeffe:
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,
Kimberly Ferlin, PhD For Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
510(k) Number (if known)
Device Name
SURGIPHOR™ Wound Irrigation System
Indications for Use (Describe)
The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
3
510(k) Summary for K202071
In accordance with 21 CFR 807.87 (h) and 21 CRF 807.92, the 510(k) summary for the SURGIPHOR™ Wound Irrigation System is provided below.
| Date | July 24, 2020 |
|---|---|
| Submitted by | Orthophor, LLC |
| 125 S. 9th Street | |
| Sheridan Building, Suite 1001 | |
| Philadelphia, PA 19107 | |
| Phone: (215) 801-1590 | |
| 510(k) Contact | Secure BioMed Evaluations |
| Elizabeth O'Keeffe | |
| 7828 Hickory Flat Highway Suite 120 | |
| Woodstock, GA 30188 | |
| 770-837-2681 (direct) | |
| Regulatory@SecureBME.com | |
| Trade Name | SURGIPHOR™ Wound Irrigation System |
| Common Name | Jet Lavage |
| Code -Classification | FQH: Class II, 21 CFR 880.5475 |
| Predicate Device | K080779, Irrisept™ Wound Debridement and Cleansing System |
| Secondary Predicate Device | K181428, Clyra Wound Irrigation Solution |
Device Description
SURGIPHOR™ Wound 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™ (0.5% Povidone lodine) solution which is used first to loosen wound debris, and one bottle of SurgiRinse™ 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 from wounds. The SURGIPHOR™ Wound Irrigation System is provided as a two part terminally sterilized system with 475 mL of each solution. 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.
Intended Use/Indications for Use
The SURGIPHOR™ Wound Irrigation System is a wound cleansing delivery system intended to loosen and remove wound debris.
4
Technological Characteristics
The subject device has the same intended use as the predicate device and substantially equivalent technological characteristics as the predicate device and/or the secondary predicate device in terms of principles of operation, material performance, and biocompatibility.
Predicate Comparison Justification
The SURGIPHOR™ Wound Irrigation System is substantially equivalent to an FDA 510(k) Cleared predicate device and shares technological features with one FDA 510(k) Cleared secondary predicate device. The following sections summarize the testing that was performed to demonstrate substantial equivalence to the predicate device.
Non-clinical Testing – Bench Study Comparison
The subject device has mechanical properties substantially equivalent to commercially available devices with the same intended uses. The following characteristics were evaluated:
Performance Testing
| Device
| Component | pH | Osmolality | Chemical Analysis | Particulates |
|---|---|---|---|---|
| SURGIPHOR™ | X | NA | X | X |
| SurgiRinse™ | X | X | NA | X |
The subject device was also tested to show equivalent mechanical action to the predicate device, demonstrating that the pressure produced during the use of the device is sufficient to agitate, loosen and remove debris from wounds.
Further testing to demonstrate the device preservative povidone is effective throughout the intended use duration of the device (24 hours after opening) was conducted following USP.
Performance Testing – Animal Study
The SURGIPHOR™ Wound Irrigation System was evaluated in a full thickness porcine wound healing model demonstrating that the test article does not appear to inhibit normal wound healing when compared to the predicate device.
Non-Clinical Testing – Biocompatibility
The SURGIPHOR™ Wound Irrigation System is categorized as a surface device with limited contact with breached or compromised surfaces per ISO 10993-1 2007, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and FDA's Guidance for Industry and Food and Drug Administration Staff "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" (June 16, 2016). The device was evaluated for the appropriate biocompatibility characteristics,
5
as well as conducting a Toxicological Risk Assessment to evaluate the safety of the device and each of the device components.
Clinical Testing
The SURGIPHOR™ Wound Irrigation System was evaluated in a Human Repeat Insult Patch Test with a primary endpoint assessing the irritation potential in humans. Additionally, a Human Abraded Skin Patch Test for Pyrogenicity was conducted with a primary endpoint of assessing the potential for pyrogenic response in humans.
Substantial Equivalence Discussion
The SURGIPHOR™ Wound Irrigation system is substantially equivalent in function and intended use to the predicate device. A comparison of the subject device to the predicate device and secondary predicate device is shown in the following table.
| Trait | SURGIPHOR™ Wound
Irrigation System | IRRISEPT Wound
Debridement and
Cleansing System
(Predicate Device) | Clyra Wound Irrigation
Solution
(Secondary Predicate
Device) | Comparison/
Equivalent to |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|
| 510(k) number | K202071 | K080779 | K181428 | N/A |
| FDA Regulation | 880.5475 | 880.5475 | Unclassified | Same as
predicate |
| Product Code | FQH | FQH | FRO | Same as
predicate |
| Product
Classification | Class II | Class II | Unclassified | Same as
predicate |
| Use | Prescription Use
Part 21 CFR 801 Subpart D | Prescription Use
Part 21 CFR 801 Subpart D | Prescription Use
Part 21 CFR 801 Subpart D | Equivalent to
predicate device |
| Intended Use | The SURGIPHOR™ Wound
Irrigation system is a
wound cleansing delivery
system intended to loosen
and remove wound debris | The IRRISEPT™ Wound
Debridement and
Cleansing System is a
wound cleansing delivery
system. The mechanical
action effectively loosens
and removes wound
debris | Clyra Wound Irrigation
Solution is intended for
use by healthcare
professionals for
cleansing, irrigating,
moistening and debriding
to remove wound debris
from acute and chronic
dermal lesions that are
partial or full thickness
wounds such as 1st and
2nd degree burns, stage I
- IV pressure ulcers,
diabetic ulcers, stasis
ulcers, abrasions and
minor skin irritations, post
surgical wounds, grafted
and donor sites, in
addition to moistening
and lubricating absorbent
wound dressings | Equivalent to
predicate |
| Mechanism of
Action | Agitate and mechanically
loosen and remove
wound debris | Agitate and mechanically
loosen and remove
wound debris | Agitate and mechanically
loosen and remove
wound debris | Equivalent to
predicate devices |
6
| Trait | SURGIPHOR™ Wound
Irrigation System | IRRISEPT Wound
Debridement and
Cleansing System
(Predicate Device) | Clyra Wound Irrigation
Solution
(Secondary Predicate
Device) | Comparison/
Equivalent to |
|-------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| Composition | 0.5% Povidone lodine
0.9% Saline
Phosphate Buffered Saline
TPGS Vitamin E
Potassium Iodide | 0.05% Chlorhexidine
Gluconate
0.9% Saline | Copper Sulphate
Potassium Iodide
Sodium Chloride
Water | Equivalent to
predicate (does
not raise
different
questions of
safety or
effectiveness),
similar to
secondary
predicate device |
Substantial Equivalence Conclusions
The intended use is identical and the Indications for Use statement for the SURGIPHOR™ Wound Irrigation System is substantively the same as that of the predicate device. The differences in ingredients do not raise different questions of safety or effectiveness. The performance testing and Toxicological Risk Assessment demonstrate that the SURGIPHOR™ Wound Irrigation System is at least as safe and effective as the predicate. Therefore, the information in this premarket notification demonstrates that the SURGIPHOR™ Wound Irrigation System is substantially equivalent to the predicate device.