(160 days)
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue. The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer. To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.
This document describes information about the Instalife Hemorrhoidal Cooling Device, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Test Protocols) | Reported Device Performance (Summary of Results) |
|---|---|
| Inflated Static Load Pull Test (VV0001P) | Passed |
| Balloon Burst Volume Test (VV0002P) | Passed |
| Compression Test (VV0007P, VV0009P) (Against Predicate Aniuce) | Both Devices Passed (Instalief™ and Predicate) |
| Cold Duration Test (VV0003P, VV0008P) (Against Predicate Aniuce) | Cold duration similar to predicate |
| In-vitro cytotoxicity – Elution method | Non-cytotoxic |
| Skin sensitization test in guinea pigs (guinea pig maximization test) | Non-sensitizing |
| Intracutaneous reactivity test in New Zealand white rabbits | Non-reactive |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each non-clinical test (e.g., number of devices tested for balloon burst or cold duration). The data provenance is derived from these non-clinical tests performed by the manufacturer, Privi Medical Pte Ltd. It is a retrospective evaluation of the device's performance against established test protocols. The country of origin for the data (where the tests were conducted) is not specified, but the company is located in Singapore.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. The "ground truth" for the non-clinical tests was established by objective performance metrics derived from laboratory testing, not expert consensus on medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As the tests were non-clinical performance and safety evaluations, there was no adjudication method involving human interpretation. The results were objectively determined based on test protocol criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical testing is not applicable for establishing substantial equivalence of Instalief™."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
This question is not applicable as the device is a physical medical device (a hemorrhoid cooling device), not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. The Type of Ground Truth Used
The ground truth used for demonstrating substantial equivalence was primarily based on:
- Performance Documentation (Test Protocols): Objective criteria for structural integrity, functional performance (like cold duration), and biocompatibility detailed in specific test protocols (e.g., VV0001P, VV0002P).
- Comparison to Predicate Device: Direct comparison of physical characteristics and functional performance against the predicate device (Anuice) also served as a "ground truth" for showing similar safety and effectiveness.
8. The Sample Size for the Training Set
Not applicable. The Instalief™ device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set, there is no ground truth establishment for it.
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January 10, 2018
Privi Medical Pte Ltd % Alan Donald, MS, MBA, RAC President Matrix Medical Consulting, Inc. 8880 Rio San Diego Drive, Suite 800 San Diego. CA 92108
K172358 Trade/Device Name: Instalief Regulatory Class: Unclassified Product Code: LKX Dated: December 16, 2017 Received: December 19, 2017
Dear Alan Donald:
Re:
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. 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.
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(Sections 531-542 of the Act); 21 CFR 1000-1050.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K172358
Device Name Instalief
Indications for Use (Describe)
Instalief is a single use device for the treatment of hemorrhoids by applying it directly to the sworthoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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Privi Medical Pte Ltd Instalief™ Traditional 510(k) Section 5 - Summary of Safety and Effectiveness
Section 5 - Summary of Safety and Effectiveness
1. Submitter's Information:
Company Name: Privi Medical Pte. Ltd. Company Address: 79 Ayer Rajah Crescent #05-03, Singapore 139955 Company Phone Number: (415) 906-5188 (USA) Contact: Mr. Prusothman M Sina Raja, CEO Establishment Registration Number: Not yet obtained.
Device Trade Name: Instalief™ Common Name: Hemorrhoid Cooling Device Classification Name: Device, Thermal, Hemorrhoids (LKX) Product Code: LKX
2. Authorized Contact Person:
Name: Prusothman M Sina Raja Email: prusothman@privimedical.com, prusothman@gmail.com Telephone: (65) 93393513 (Singapore) / (415) 906-5188 (USA)
3. Company Device Information:
Device Name: Instalief™ Classification: Unclassified (Pre-Amendment)
4. Predicate Device Information:
Device Name: ANUICE Cryotherapy Pain Relief Products, Inc. Classification: Unclassified (Pre-Amendment) 510(k): K981428 Product Code: LKX
5. Submission Information:
Date Summary Prepared: 11th July 2017 Prepared by: Prusothman M Sina Raja
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6. Device Description
Instalief™ is a device designed for the treatment of internal and external hemorrhoids by the application of cold directly to the swollen hemorrhoidal tissue.
The device consists of an outer bag which houses an endothermic salt, a smaller water-containing frangible bag, an insertion tip with an attached compliant balloon, as well as a separate component that aids in the usage of the device, known as the squeezer.
To use the device, the user first bursts the frangible bag by pressing on it, initiating an endothermic process between the water and endothermic salt. The user then inserts the shaft of the device into the anal canal (for internal hemorrhoids) or applies to the outer tissues (for external hemorrhoids), and squeezes the bag with the aid of the squeezer. This action transfers the cold fluid generated into the balloon, which provides targeted cold therapy to the hemorrhoids. Instalief™ is meant to be used for 6 - 8 minutes.
In terms of physical characteristics, Instalief™ is anatomically designed by taking into account human anatomical characteristics. The introducer and balloon, which comes into contact with the user, is made from medical-grade material and conforms to the biocompatibility requirements of the device class. The introducer has filleted edges and a tapered shaft for smooth insertion into the anal. It is also designed with a functional length long enough to reach the internal hemorrhoids, as well as a flared base to physically prevent over-insertion. The balloon dimensions were chosen to allow for safe inflation without compromising the integrity of the material.
7. Indications for Use
Instalief™ is a single use device for the treatment of hemorrhoids by applying it directly to the swollen hemorrhoidal tissues. By applying cold to the tissue, the inflammation is reduced. The device can be used for the treatment of external hemorrhoids and internal hemorrhoids. The device is for adults only.
8. Substantial Equivalency
Instalief™ is substantially equivalent to Anuice and raises no new safety or effectiveness issues.
8.1. Non-Clinical Testing
The following tests were performed on Instalief™ and the predicate device (where applicable), for the comparison of functional performance and evaluation
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of both structural integrity and biocompatibility.
| Structural Integrity | |
|---|---|
| Performance Documentation (TestProtocols) | Summary of Results |
| Inflated Static Load Pull Test- VV0001P | Passed |
| Balloon Burst Volume Test- VV0002P | Passed |
| Compression Test (Against Predicate)- VV0007P- VV0009P | Both Devices Passed |
| Functional Performance | |
| Performance Documentation (TestProtocols) | Summary of Results |
| Cold Duration Test (Against Predicate)- VV0003P- VV0008P | Cold duration similar to predicate |
| Biocompatibility | |
| Test Information and Details | Summary of Results |
| In-vitro cytotoxicity – Elution method | Non-cytotoxic |
| Skin sensitization test in guinea pigs (guineapig maximization test) | Non-sensitizing |
| Intracutaneous reactivity test in New Zealandwhite rabbits | Non-reactive |
8.2. Clinical Testing
Clinical testing is not applicable for establishing substantial equivalence of Instalief™.
8.3. Comparison Table of New and Predicate Device
| Features and Specifications | InstaliefTM | Anuice | Notes | |
|---|---|---|---|---|
| 1 | Mode of action | Application of cold to hemorrhoidal tissue | Application of cold to hemorrhoidal tissue | Same |
| 2 | Max insertion | Up to 25mm into | Up to 45mm into | Smaller initial insertion |
| depth | the anal canal (forinternalhemorrhoids) | the anal canal (forinternalhemorrhoids) | depth for Instalief™ | |
| 3 | Max workingdepth | Up to 55mm intothe anal canal (forinternalhemorrhoids) | Up to 45mm intothe anal canal (forinternalhemorrhoids) | Both depths are in similarrange. The slightly deeperworking depth ensuresbetter coverage ofhemorrhoidal region. |
| 4 | Insertion depthlimiter | Flared basecomponent | Flared basecomponent | Same. Both designed tophysically limit insertiondepth. |
| 5 | Insertion OD | 7 mm (withoutballoon inflation)30 mm maximum(with ballooninflation) | 11mm | A smaller insertion ODallows for easier and morecomfortable insertion andremoval.The balloon is expandedafter insertion into the analcanal, and is deflated priorto being withdrawn. |
| 6 | Cold source | Chemical(endothermicprocess) | Physical (phasechange) | Similar. In Instalief™, thecold source is generatedthrough an endothermicreaction, while the predicatedevice achieves this througha physical change of state ofits contained substance.Both devices function usingthe principle of coldtherapy. |
| 7 | Shaft material | Silicone Rubber(introducer) | Rigid plastic | Soft flexible shaft reducesthe risk of tissue damagecaused by erroneousinsertion technique |
| 8 | Cold therapydelivery | Delivered via acompliant balloon | Delivered via ahollow shaft | The balloon is a better coldtherapy delivery componentas it conforms to the shapeof the anal canal |
| 9 | Removalmechanism | Deflate balloonfollowed bywithdrawal | Withdrawal ofdevice | Similar |
| 10 | Base | PVC Bag | Hard plastic | Bag is designed to |
| withstand the require backpressure during usage (seeVV0007P) | ||||
| 11 | Anatomicallydesigned | Yes. General designcharacteristics:1. Tapered shaftextending into analcanal2. “Base” feature toprevent over-insertion of device3. Smooth roundedcorners4. No sharp edges | Yes. Generaldesigncharacteristics:1. Tapered shaftextending intoanal canal2. “Base” featureto prevent over-insertion ofdevice3. Smoothrounded corners4. No sharp edges | Same. Similar designcharacteristics meant tofacilitate insertioninto/removal out of the analcanal. |
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Privi Medical Pte Ltd
Instalief™
Traditional 510(k) Section 5 - Summary of Safety and Effectiveness
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Privi Medical Pte Ltd Instalief™ Traditional 510(k)
Section 5 - Summary of Safety and Effectiveness
- 8.4. Studies Cited for Substantial Equivalence Discussion
- 8.4.1. Ratuapli, M. D. et al.(2013). Comparison of rectal balloon expulsion test in seated and left lateral positions. Neorugastroenterol Motil. 25(12). Doi:10.1111/nmo.12208
- 8.4.2. Padda, B. S. et al. (2006). Effects of pelvic floor muscle contraction on anal canal pressure. Am J Physiol Gastrointest Liver Physiol. 292: G565-G571. Doi:10.1152/ajpgi.00250.2006
- 8.4.3. Duthie, H. L., Bennett, R. C. (1963). The relation of sensation in the anal canal to the functional anal sphincter: a possible factor in anal continence. Gut,4, 179-182. Doi:10.1136/gut.4.2.179
- 8.5. Referenced Devices
- 8.5.1. GelPOINT Path Transanal Access Platform (K133393)
9. Conclusion
Based on the comparison of intended use, indications for use, non-clinical testing, literature, biocompatibility testing and technological characteristics, the Instalief™ is substantially equivalent to Anuice (K981428) and raises no new safety or effectiveness issues.
N/A