(130 days)
Not Found
No
The description focuses on a manual irrigation device with a chemical solution and mechanical action. There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
A therapeutic device is one that treats or cures a disease or medical condition. This device is described as a "wound cleansing delivery system" that "effectively loosens and removes wound debris," which is a cleansing action rather than a therapeutic one. The CHG acts as a preservative for the solution, not as a therapeutic agent for the wound itself.
No
The device is described as a wound cleansing delivery system that mechanically loosens and removes wound debris, which is a therapeutic action, not a diagnostic one.
No
The device description clearly outlines physical components: a bottle of solution and an applicator. The performance studies also focus on physical characteristics like sterilization, packaging, and biocompatibility, which are not relevant to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "wound cleansing delivery system" and "mechanical action effectively loosens and removes wound debris." 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 "single-use, manual, self-contained irrigation device" containing a solution for wound cleansing. This aligns with a therapeutic or procedural device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device's function is purely for the physical cleansing of a wound.
N/A
Intended Use / Indications for Use
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
Product codes
FOH, FRO
Device Description
Irrisept® Wound Debridement and Cleansing System is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Wound
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
Performance testing demonstrates that the subject Irrisept is as safe and as effective as the predicate, predecessor Irrisept product. These tests include:
- Preservative Antimicrobial Effectiveness
- USP Antimicrobial Effectiveness Testing
- Aseptic Processing
- ISO 13408 Aseptic Processing of Health Care Products
- Sterilization
- ISO 11135 Sterilization of Health-Care Products Ethylene Oxide
- ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals
- USP Sterility Tests
- AAMI TIR 28 Product adoption and process equivalence for ethylene oxide sterilization
- Endotoxins and Pyrogens
- USP Bacterial Endotoxins Test
- USP Pyrogen Test (USP Rabbit Test)
- USP Medical Devices Bacterial Endotoxin and Pyrogen Tests
- Packaging and Shelf-Life
- ISO 11607 Packaging for Terminally Sterilized Medical Devices
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
- ASTM F2096-11 Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping Containers and Systems
- Biocompatibility
- ISO 10993- Biological Evaluation of Medical Devices
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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December 14, 2020
Image /page/0/Picture/1 description: The image contains 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 logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Irrimax Corporation Christy Coleman VP Regulatory 1665 Lakes Parkway - Suite 102 Lawrenceville, Georgia 30043
Re: K202222
Trade/Device Name: Irrisept Wound Debridement and Cleansing System Regulation Number: 21 CFR 880.5475 Regulation Name: Jet Lavage Regulatory Class: Class II, unclassified Product Code: FOH, FRO Dated: November 12, 2020 Received: November 13, 2020
Dear Christy Coleman:
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 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
1
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 (OS) 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,
For Kimberly Ferlin, Ph.D. Assistant Director (acting) 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
510(k) Number (if known) K202222
Device Name
Irrisept Wound Debridement and Cleansing System
Indications for Use (Describe)
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
| 510(K) NUMBER: | K202222 |
|---|---|
| PREPARATION DATE: | December 11, 2020 |
| APPLICANT: | Irrimax® Corporation |
| 1665 Lakes Parkway, Suite 102 | |
| Lawrenceville, GA 30043 | |
| CONTACT PERSON: | Christy Coleman, OD, MPH |
| Vice President, Regulatory Affairs, Irrimax® | |
| Corporation | |
| Tel: (770) 807-3355 | |
| DEVICE TRADE NAME: | Irrisept® Wound Debridement and |
| Cleansing System | |
| CLASSIFICATION NAME: | Jet Lavage |
| DEVICE CLASSIFICATION: | Class II (21 CFR 880.5475) |
| Unclassified (Pre-amendment) | |
| PRODUCT CODE: | FQH; FRO |
| PREDICATE DEVICE: | Irrisept® Wound Debridement and Cleansing System |
| (K080779) | |
| • Product Code FQH (Jet Lavage); | |
| Class II (21 CFR 880.5475) | |
| • Product Code FRO (Dressing, Wound, | |
| Drug); Unclassified (pre-amendment) | |
| Applicant: Irrimax Corporation |
DEVICE DESCRIPTION:
Irrisept® Wound Debridement and Cleansing System is a single-use, manual, self-contained irrigation device comprised of a 450mL bottle of 0.05% Chlorhexidine Gluconate (CHG) in 99.95% Sterile Water for Irrigation, United States Pharmacopeia (USP) and an applicator (labeled Irriprobe®). The solution is aseptically-filled in a Blow-Fill-Seal (BFS) bottle. The CHG acts as a preservative to inhibit microbial growth in the solution.
INTENDED USE/INDICATIONS FOR USE:
The Irrisept Wound Debridement and Cleansing System is a wound cleansing delivery system. The mechanical action effectively loosens and removes wound debris.
4
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS:
The Irrisept that is the subject of this 510(k) is substantially equivalent to its predicate, predecessor K080779 Irrisept. This is a catch-up 510(k) submission intended to update the Irrisept record at FDA with the changes that have been implemented in the subject product. As such, the intended use/indications remain identical to that for the cleared product. Further, the implemented changes were primarily to be responsive to user feedback, capture the now available longer-term shelf-life data, or reflect a need to change a supplier or manufacturing contractor. These are captured in the comparison table below.
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
|---|---|---|
| Comparison Feature | Cleared Irrisept Product | |
| (K080779) | Subject Irrisept Product | |
| (K202222) | ||
| Intended Use/ | ||
| Indications for Use | The Irrisept Wound | |
| Debridement and Cleansing | ||
| System is a wound cleansing | ||
| delivery system. The | ||
| mechanical action effectively | ||
| loosens and removes wound | ||
| debris. | Identical | |
| Rx only | Prescription Product | Identical |
| Single Use | Single Use | Identical |
| Mechanism of Action | The mechanical action of fluid | |
| across the wound removes | ||
| wound debris. | Identical. | |
| Components and | ||
| Materials | Polypropylene bottleSolutionPolycarbonate applicator | New supplier for |
| Chlorhexidine GluconateNew supplier for | ||
| polycarbonate | ||
| Solution Composition | 0.05% Chlorhexidine Gluconate | |
| in 99.95% Sterile Water for | ||
| Irrigation, USP | Identical | |
| Container Design | 450 mL BFS bottle delivers fluid | |
| by manual compression | Identical | |
| Applicator Design | Multi-port applicator that | |
| threads onto bottle. | Multi-port applicator that | |
| threads onto bottle and with | ||
| a longer tip.Change to a higher capacity | ||
| manufacturing mold | ||
| Biocompatibility | Conforms to ISO 10993-1 for a | |
| surface device with breached or | ||
| compromised surface contact | ||
| and a limited contact duration | ||
| (≤ 24 hours) | Identical | |
| COMPARISON OF TECHNOLOGICAL CHARACTERISTICS | ||
| Comparison Feature | Cleared Irrisept Product | |
| (K080779) | Subject Irrisept Product | |
| (K202222) | ||
| Manufactured using | ||
| Aseptic Techniques | Solution is manufactured using Blow-Fill-Seal (BFS) aseptic processing. Solution labeled as Sterile. | Identical BFS process New contract manufacturer Changed to a higher capacity BFS manufacturing mold |
| Non-Pyrogenic | Solution | Solution and applicator |
| Endotoxin Limit ≤ 20 EU/device | ||
| ( Antimicrobial Effectiveness Testing |
- Aseptic Processing
- o ISO 13408 Aseptic Processing of Health Care Products
- Sterilization
- ISO 11135 Sterilization of Health-Care Products Ethylene Oxide O
- ANSI AAMI ISO 10993-7 Ethylene oxide sterilization residuals O
- USP Sterility Tests O
- AAMI TIR 28 Product adoption and process equivalence for ethylene oxide O sterilization
- Endotoxins and Pyrogens ●
- USP Bacterial Endotoxins Test O
- USP Pyrogen Test (USP Rabbit Test) O
- USP Medical Devices Bacterial Endotoxin and Pyrogen Tests O
● 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 Packaging о by Internal Pressurization (Bubble Test)
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous o Medical Packaging by Dye Penetration
- ASTM D4169-16 Standard Practice for Performance Testing of Shipping o Containers and Systems
- Biocompatibility ●
- o ISO 10993- Biological Evaluation of Medical Devices
CONCLUSIONS:
In conclusion, Irrimax has demonstrated through performance testing that the subject Irrisept is substantially equivalent to its predicate Irrisept product in intended use and technological characteristics.