(74 days)
Not Found
No
The device description and intended use are purely mechanical and do not mention any computational or data-driven features. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No.
The device is intended for "temporary relief from the pain and pressure of hemorrhoids" and is an over-the-counter toilet seat accessory, not a medical device that treats or cures a condition. Its function is purely mechanical, providing a comfortable seating arrangement for individuals with hemorrhoids.
No
The device description and intended use indicate it is a plastic seat for temporary relief of hemorrhoid symptoms, not for diagnosing medical conditions.
No
The device description clearly states it is an "injection molded polypropylene copolymer plastic seat," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens from the human body. This includes things like blood, urine, tissue, etc., to provide information about a person's health.
- The Hemaway Seat is an external device. It is a physical seat that attaches to a toilet and is used externally for temporary relief of hemorrhoid symptoms. It does not involve the collection or analysis of any bodily specimens.
The description clearly states the device is for "external use only" and is a physical seat. This aligns with a medical device used for physical support and relief, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Hemaway Seat is for the temporary relief from the pain and pressure of hemorrhoids. The device is for external use only.
Product codes (comma separated list FDA assigned to the subject device)
LRL
Device Description
The Hemaway Seat is an injection molded polypropylene copolymer plastic seat attached to a toilet seat that discretely locks into the contoured lid when not in use. The product is adjustable and is available in round and elongated versions. The product is assembled and attaches to the toilet in the same manner as a regular toilet seat. The user is instructed to sit on the seat facing forward in the same manner as sitting on a conventional toilet seat, positioned so that the hemorrhoids are in the center of the seat opening. This is intended to create a slight counter-pressure around the anal canal, which gently relieves the pain and pressure of the hemorrhoids.
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
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)
Not Found
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.
Not Found
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
N/A
0
Image /page/0/Picture/0 description: The image shows the number "1068" written in the top left corner. Below that is the number "K072690". At the bottom of the image is a logo that is a black square with a white crescent shape at the bottom.
HEMAWAY LLC RELIEF SOLUTIONS
DEC 0 7 2007
510(k) Summary
Hemaway Seat
The following information is presented as required by 21 C.F.R. § 807.92:
Date:
November 20, 2007
Section A: Administrative Information
Submitter:
Hemaway LLC 2207 Concord Pike PMB 528 Wilmington, Delaware 19803
Establishment Registration Number:
Manufacturing Site:
Midbury Industries Inc. 86 East Merrick Road Freeport, NY 11520 (216) 868-0600
To be obtained
Contact Person:
Archie Rosenblum
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Image /page/1/Picture/0 description: The image shows a handwritten text that appears to be a combination of numbers and letters. At the top, there's a faded inscription that looks like "2018". Below this, there is a more distinct alphanumeric code "K072690". The handwriting is somewhat rough, with varying stroke thicknesses, suggesting it may have been written quickly or with a worn writing instrument.
:
:
Section B: Device Identification
Performance Standards:
and the comments of the comments of the comments of
| Device Name: | Hemaway Seat |
|---|---|
| Common Name: | Hemorrhoid Seat |
| Device Classification: | Unclassified |
| Panel: | Gastroenterology/Urology |
| Performance Standards: | None known established |
2
Image /page/2/Picture/0 description: The image shows a handwritten text that appears to be a combination of numbers and letters. The numbers '248' are at the top, with the number '15' below it. The letters 'Kc' are on the bottom left, followed by the numbers '72690'. The handwriting is somewhat faded and has a rough texture.
Section C: Device Description
The Hemaway Seat is an injection molded polypropylene copolymer plastic seat attached to a toilet seat that discretely locks into the contoured lid when not in use. The product is adjustable and is available in round and elongated versions. The product is assembled and attaches to the toilet in the same manner as a regular toilet seat. See illustrations below.
Image /page/2/Figure/3 description: The image shows a toilet seat with the lid open. The toilet seat is oval-shaped and has a slightly raised edge. The lid is also oval-shaped and is attached to the seat by hinges. The lid is open and is resting against the back of the toilet. The toilet seat and lid are both made of a smooth, light-colored material.
Figure 1
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74.3
K072690
Image /page/3/Picture/1 description: The image shows a toilet seat with the lid partially open. The seat and lid are oval-shaped. The seat is raised above the toilet bowl, and there is a support structure visible between the seat and the bowl. The image is in black and white.
Figure 2
4
548
K177690
Image /page/4/Picture/1 description: The image shows a toilet seat in an open position. The lid is raised high, and the seat is also lifted, revealing the opening. The toilet seat appears to be made of a smooth, possibly plastic, material. The image is a black and white rendering.
Figure 3
:
5
Image /page/5/Picture/0 description: The image shows two lines of handwritten text. The first line appears to be "6958", while the second line reads "Ki072690". The text is written in a cursive style, and the image has a slightly grainy texture.
Image /page/5/Picture/1 description: The image shows a toilet seat with a lid. The toilet seat is oval-shaped and has a handle in the middle. The lid is also oval-shaped and is slightly open. The toilet seat and lid are both made of a light-colored material. The image is a close-up of the toilet seat and lid.
Figure 4
The user is instructed to sit on the seat facing forward in the same manner as sitting on a conventional toilet seat, positioned so that the hemorrhoids are in the center of the seat opening. This is intended to create a slight counter-pressure around the anal canal, which gently relieves the pain and pressure of the hemorrhoids.
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7-88
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Hemaway Seat
The Hemaway Seat is for the temporary relief from the pain and pressure Indications for Use: of hemorrhoids. The device is for external use only.
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use Prescription Use _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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K072690
Section D: Substantial Equivalence
| Predicate Devices: | HemorestTM (K864470) |
|---|---|
| The Derby Raised Toilet Seat (K821860) |
Narrative Description of Substantial Equivalence:
The Hemaway Seat is substantially equivalent to other FDA listed and 510(k) cleared hemorrhoid cushions. Specifically, the Hemaway Seat has the same intended use and similar physical characteristics as the Hemorest device. Although essentially the same in all significant respects, the Hemaway Seat is made of plastic while the Hemorest is made of foam, the Hemaway Seat attaches to a toilet while the Hemorest is portable, and the Hemaway Seat does not contain a crown feature but rather is available in two sizes.
The Hemaway Seat is also substantially equivalent to FDA listed and cleared raised toilet seats, such as the Derby Raised Toilet Seat, in material (polypropylene plastic), biocompatibility and method of use (i.e., skin-to-product contact while seated). A comparison of the characteristics of the current device and the predicate devices is set forth in the chart below.
| Feature | Hemaway | Hemorest | Derby |
|---|---|---|---|
| Used in a sitting position | Yes | Yes | Yes |
| Provides temporary relief from the pressure and pain of hemorrhoids | Yes | Yes | No |
| Noninvasive | Yes | Yes | Yes |
| Contains a “crown” as a component of the device | No | Yes | No |
| Can be used in conjunction with other treatments | Yes | Yes | Yes |
| Made of polypropylene plastic | Yes | No | Yes |
| Integrated into toilet seat | Yes | No | Yes |
| Portable | No | Yes | No |
| Has direct contact with the body while sitting | Yes | No | Yes |
| Available in 2 sizes | Yes | No | Yes |
Comparison Chart:
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 7 2007
Mr. Archie Rosenblum Hemaway LLC 2207 Concord Pike, Suite 528 PMB 528 WILMINGTON DE 19803
Re: K072690
Trade/Device Name: Hemaway Seat Regulation Number: None Regulatory Class: Unclassified Product Code: LRL Dated: November 20, 2007 Received: November 21, 2007
Dear Mr. Rosenblum:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
9
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); 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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×
Indications for Use
510(k) Number (if known): K072690
Hemaway Seat Device Name:
The Hemaway Seat is for the temporary relief from the pain and pressure Indications for Use: of hemorrhoids. The device is for external use only.
Over-The-Counter Use __ Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hala Penner
(Division Sign-Off)
Division of Reproductive, Abdominal and
radiological Devices
10(k) Number
K072690
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