(250 days)
Not Found
No
The device is a sterile anti-fog solution and sponge, with no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is an anti-fog solution for surgical camera lenses, not a therapeutic agent applied to a patient.
No
Explanation: The device is an anti-fog solution for endoscopic and laparoscopic cameras, designed to prevent fogging and ensure clearer vision during surgery. It does not collect, process, or analyze patient data to diagnose a disease or condition.
No
The device is a sterile anti-fog solution and an adhesive-backed sponge, which are physical components, not software. The description focuses on the chemical and physical properties and performance of these components.
Based on the provided information, the GOLFF Sterile Anti-Fog Solution is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The GOLFF solution is applied to the lenses of endoscopic and laparoscopic cameras, which are external to the body and are used to visualize internal structures.
- The intended use is to prevent fogging on camera lenses. This is a functional purpose related to the imaging equipment, not a diagnostic test performed on a biological sample.
- The device description focuses on its physical properties and anti-fogging function. There is no mention of analyzing biological samples or providing diagnostic information.
The GOLFF Sterile Anti-Fog Solution is clearly described as a medical device used to improve the functionality of other medical devices (endoscopic and laparoscopic cameras) during surgical procedures.
N/A
Intended Use / Indications for Use
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
Product codes
OCT
Device Description
GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.
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
hospital staff / Hospital O.R. Room
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
A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution. The following test results conducted to confirm the product is safe and effective as indicated.
Product Functional Testing:
- Deformation/Degradation: Pass
- Easy Removal of Release Liner: Pass
- Adhesive Backing Functional: Pass
- Squeeze Test: Pass
- Transparency of Bottle: Pass
- Bottle Shape: Pass
- Anti-Fog Functional Test: Pass
Biocompatibility testing:
- Cytotoxicity Test (ISO 10993-5:2009): Pass: Non-Cytotoxic
- Sensitization Test (ISO 10993-10:2010): Pass: Non-Sensitizing
- Intracutaneous Reactivity Test (ISO 10993-10:2010): Pass: Non-Irritating
All tests mentioned above showed that GOLFF Sterile Anti-Fog Solution did not raise any safety issues and is biocompatible.
Sterilization Validation and Shelf-Life Study:
The product is designed to undergo gamma-radiation sterilization prior to place into the market. The gamma-radiation sterilization validation study was performed, and passed, per the requirements of the FDA recognized consensus standards listed below:
- ISO 11137-2:2013 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose
- ISO 11737-1:2018 Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of A Population of Microorganisms on Products
- ISO 11737-2:2019 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in The Definition, Validation, and Maintenance of a Sterilization Process
Product Aging Validation Study (Accelerated aging testing) to simulate 4 years of aging:
- Package Integrity Test (Dye penetration Test) (ASTM F1929-15): Pass
- Seal Peel Strength Test (ASTM F88/F88M-15): Pass
- Product Sterility Test (ISO 11737-2:2019): Pass
- Product Stability Studies (Fog Resistance Test) (N/A (followed by the internal testing protocol)): Pass
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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.
February 26, 2024
Batrik Medical Manufacturing Inc. Suzy Bairos President 2165 46th Ave Lachine, Quebec H8T 2P1 Canada
Re: K231822
Trade/Device Name: GOLFF Sterile Anti-Fog Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope And Accessories Regulatory Class: Class II Product Code: OCT Dated: January 25, 2024 Received: January 25, 2024
Dear Suzy Bairos:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231822
Device Name GOLFF Sterile Anti-Fog Solution
Indications for Use (Describe)
The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
| 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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4
SECTION 5.0-510 (k) Summary
Image /page/4/Picture/1 description: The image shows a partial view of a document or advertisement. At the top, there's a mathematical expression that includes the number 310 followed by '(K)'. Below this, there's a vertical block of text in a bold, sans-serif font. The text appears to be part of a brand name or title, with the letters 'TRIK' being prominently visible. The color scheme includes a bright, solid blue that contrasts with the white text.
Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com
1. Submitter Information:
Date of 510(k) Summary: 1/24/2024 Submitter: Batrik Medical Manufacturing Inc Preparer and Contact Name: Heli Thakkar, Regulatory and Quality Manager Email: hthakkar@surgmed.com 510(k) Owner: Suzy Bairos, President Email: sbairos@surgmed.com Address: 2165 46th Ave., Lachine, Quebec, H8T 2Pl, Canada Phone: 514-631-7988 Ext. 21 / Fax: 514-631-9083
2. Device Name and Classification:
| Common Name of Device: | Anti-Fog Solution |
|---|---|
| Device Proprietary Name: | GOLFF Sterile Anti-Fog Solution |
| Review Panel: | Gastroenterology/Urology |
| Regulation Number: | 21 CFR 876.1500 |
| Regulation Name: | Endoscope and Accessories |
| Class: | II |
| Product Code: | OCT |
3. Substantial Equivalence:
Legally marketed devices with equivalence are claimed:
- Primary Predicate: Aspen Surgical Inc. Dr. Fog:510(k) K932449 .
- . Secondary Predicate: Medline Anti-Fog Solution 510(k) Kl 52948
4. Device Description:
GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.
There are no additional accessories associated with the product.
Diseases/Conditions for diagnosis, treatment, prevention, cure, or mitigation: None
Prescription Use Medical Device
5. Indications for Use:
The GOLFF Sterile Anti-Fog Solution is a single-use, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.
6. Predicate Device:
- Primary Predicate: Aspen Surgical Inc. Dr. Fog 510(k) K932449 dated 11-AUG-1993 is similar in intended use, a. handling and technology compared to the device described in this submission.
- Secondary Predicate: Medline Anti-Fog Solution 510(k) K152948 dated 04-FEB-2016 is similar in intended use, b.
5
SECTION 5.0-510 (k) Summary
Image /page/5/Picture/1 description: The image shows a logo for a company called "BATRIK MEDICAL". The logo features the company name in white text against a light blue background. Above the company name, there are several white triangles arranged in a row, resembling a mountain range. The overall design is simple and clean, with a focus on the company name and a visual element that suggests stability and reliability.
Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com
handling and technology compared to the device described in this submission.
- Comparison of Technological Characteristics with the Predicate Device: C.
| Company | Batrik Medical Manufacturing
Inc. | Primary Predicate
Aspen Surgical Inc.
(K932449) | Secondary Predicate
Medline
(K152948) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model | GOLFF Sterile Anti-Fog Solution | Dr. Fog | Medline Anti-Fog Solution |
| Classification | Class II Device, OCT | Class II Device, OCT | Class II Device, OCT |
| Indications for
Use | The GOLFF Sterile Anti-Fog Solution
is a single-use, medical device, anti-
fog solution used by hospital staff to
apply on lenses of endoscopic and
laparoscopic cameras. The solution is
provided in an easy-to- squeeze bottle
and comes with an adhesive-backed
sponge for secure placement. | Intended as an anti-fog agent for
endoscopic camera lenses. -
Removes fog formation on lens and
allows the procedure to be
uninterrupted. | Intended as an anti-fog agent for
endoscopic camera lenses. -
Removes fog formation on lens and
allows the procedure to be
uninterrupted. |
| Description | GOLFF Sterile Anti-Fog Solution by
Regulation 21 CFR 876.1500 under
FDA product code, OCT. GOLFF is
a single use, disposable medical
device provided sterile. GOLFF is
offered in a sterile, sealed pouch with
a bottle filled with anti-fog solution
and a sponge with an adhesive
backing lined with a barium strip. | Sterile Anti-Fog Solution by
Regulation 21 CFR 876.1500 under
FDA product code, OCT. A single
use, disposable medical device
provided sterile. Offered in a sterile
sealed pouch with a bottle filled
with anti-fog solution and a sponge
with an adhesive backing lined with
a barium strip. | Sterile Anti-Fog Solution by
Regulation 21 CFR 876.1500 under
FDA product code, OCT. A single use,
disposable medical device provided
sterile. Offered in a sterile sealed
pouch with a bottle filled with anti-fog
solution and a sponge with an adhesive
backing lined with a barium strip. |
| Material | Bottle, cap and tip: Polyethylene
Sponge: open cell polyester
Strip: Barium
Solution: deionized water, isopropyl
alcohol, surfactant | Bottle, cap and tip: Polyethylene
Sponge: open cell polyester
Strip: Barium
Solution: surfactant, isopropyl
alcohol, water | Unknown |
| Safety | The following biocompatibility tests
were conducted.
- Cytotoxicity Test
- Sensitization Test
- Intracutaneous
Reactivity Test
All of the tests passed the
requirements as indicated in the
applicable standards | Unknown: All of the
biocompatibility tests that are
indicated in the FDA recognized
standards were performed. | Unknown: All of the biocompatibility
tests that are indicated in the FDA
recognized standards were performed. |
| Sterility | Sterile | Sterile | Sterile |
| Use | Single Use, Disposable | Single Use, Disposable | Single Use, Disposable |
| Where is it
used | Hospital O.R. Room | Hospital O.R. Room | Hospital O.R. Room |
| Sterilization | Gamma irradiation | Gamma irradiation | Gamma irradiation |
6
SECTION 5.0-510 (k) Summary
Image /page/6/Picture/1 description: The image features a logo for "BATRIK MEDICAL". The logo is predominantly blue, with the word "BATRIK" in a bold, sans-serif font stacked above the word "MEDICAL", which is in a smaller font. Below the text, there are three small circles in a horizontal row, colored blue, green, and dark blue, respectively.
Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, H8T 2P1, Canada Phone: (800) 661-5432 | Website: www.surgmed.com
i. Performance Data
A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution. The following test results conducted to confirm the product is safe and effective as indicated.
-
- Product Functional Testing
| Benchtop Test | Batrik Medical Manufacturing Inc.
GOLFF Sterile Anti-Fog Solution |
|-------------------------------|----------------------------------------------------------------------|
| Deformation/Degradation | Pass |
| Easy Removal of Release Liner | Pass |
| Adhesive Backing Functional | Pass |
| Squeeze Test | Pass |
| Transparency of Bottle | Pass |
| Bottle Shape | Pass |
| Anti-Fog Functional Test | Pass |
ii. Biocompatibility testing
| Test | Batrik Medical Manufacturing
Inc.
GOLFF Sterile Anti-Fog Solution |
|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Cytotoxicity Test
ISO 10993-5:2009 Biological Evaluation of Medical Devices -
Part 5: Tests For In Vitro Cytotoxicity | Pass: Non-Cytotoxic |
| Sensitization Test
ISO 10993-10:2010 Biological Evaluation of Medical Devices -
Part 10: Tests For Irritation And Skin Sensitization | Pass: Non-Sensitizing |
| Intracutaneous Reactivity Test: ISO 10993-10:2010 Biological
Evaluation Of Medical Devices - Part I 0: Tests For Irritation
And Skin Sensitization | Pass: Non-Irritating |
All tests mentioned above showed that GOLFF Sterile Anti-Fog Solution did not raise any safety issues and is biocompatible.
iii. Sterilization Validation and Shelf-Life Study
The product is designed to undergo gamma-radiation sterilization prior to place into the market. The gammaradiation sterilization validation study was performed, and passed, per the requirements of the FDA recognized consensus standards listed below:
-
ISO 11137-2:2013 Sterilization of Health Care Products - Radiation - Part 2: Establishing the Sterilization Dose
-
ISO 11737-1:2018 Sterilization of Medical Devices - Microbiological Methods - Part 1: Determination of A Population of Microorganisms on Products
-
ISO 11737-2:2019 Sterilization of Medical Devices - Microbiological Methods - Part 2: Tests of Sterility Performed in The Definition, Validation, and Maintenance of a Sterilization Process
7
SECTION 5.0 - 510 (k) Summary
Image /page/7/Picture/1 description: The image shows the logo for Batrik Medical. The logo features a blue square with a stylized mountain range at the top. Below the mountain range, the word "BATRIK" is written in large, bold, white letters, with the word "MEDICAL" written in smaller, white letters underneath. At the bottom of the logo are three small circles in different shades of blue and green.
Batrik Medical Manufacturing Inc. 2165 46th Ave., Lachine, Quebec, HST 2Pl, Canada Phone: (800) 661-5432 | Website: www.surgmed.com
1. Product Aging Validation Study (Accelerated aging testing)
The product aging validation study was performed to simulate 4 years of aging.
| No. | Test Name | Applicable Standards | Comment |
|---|---|---|---|
| 1 | Package Integrity | ||
| Test | |||
| (Dye penetration | |||
| Test) | ASTM F1929-15 Standard Test Method For | ||
| Detecting Seal Leaks In Porous Medical | |||
| Packaging By Dye | |||
| Penetration | Pass | ||
| 2 | Seal Peel Strength | ||
| Test | ASTM F88/F88M-15 Standard Test Method | ||
| For Seal Strength Of Flexible Barrier Materials | Pass | ||
| 3 | Product Sterility | ||
| Test | ISO 11737-2:2019 Sterilization Of Medical | ||
| Devices - Microbiological Methods - Part 2: | |||
| Tests Of SterilityPerformed In The Definition, | |||
| Validation And Maintenance Of A | |||
| Sterilization Process | Pass | ||
| 4 | Product Stability | ||
| Studies | |||
| (Fog Resistance Test) | N/A (followed by the internal testing protocol) | Pass |
iv. Conclusions
Based on the testing conducted and equivalency in performance demonstrated between the Batrik, Aspen Surgical Inc., and Medline Inc. devices, in conjunction with biocompatibility demonstrated via EN ISO 10993-5 and EN ISO 10993-10 evaluations, evidence has been submitted to demonstrate that GOLFF Sterile Anti-Fog Solution is substantially equivalent to the predicate.