(156 days)
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No
The document describes surgical drapes and equipment covers, which are physical barriers and do not involve data processing or analysis typically associated with AI/ML. There is no mention of AI, ML, image processing, or any software-driven functionality.
No
The device, HM surgical drapes, is intended to be used as a protective patient covering to isolate surgical sites from contamination, not to treat a disease or condition.
No
The device, HM surgical drapes, is described as a protective patient covering and a barrier for surgical equipment. Its intended use is to isolate a surgical site from contamination, not to diagnose a condition.
No
The intended use and description clearly indicate the device is a physical product (surgical drapes and equipment covers) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the surgical drapes and equipment covers are used as protective barriers during surgery to prevent contamination. This is a physical barrier function, not a diagnostic function.
- Lack of Diagnostic Activity: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Focus on Sterilization and Physical Barrier: The description focuses on the sterile or non-sterile nature of the products and their use as a physical barrier.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device does not fit that description.
N/A
Intended Use / Indications for Use
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
HM surgical equipment covers are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Product codes (comma separated list FDA assigned to the subject device)
KKX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 878.4370 Surgical drape and drape accessories.
(a)
Identification. A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.(b)
Classification. Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 12, 2012
Mr. Alan Yu Manager, Quality Assurance/Regulatory Affairs Changzhou HolyMED Products Company, Limited 528 Changwu South Road Wujin District Changzhou, China 213167
Re: K122000
Trade/Device Name: HM Surgical Drapes, HM Surgical Equipment Covers Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX · Dated: November 27, 2012 Received: November 29, 2012
Dear Mr. Yu:
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.
1
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 (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 (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.
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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony De min
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
510(k) Number (if known): KI22000 .
Device Name: HM Surgical Drapes
Indications for Use:
HM surgical drapes are intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
HM surgical drapes are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical drapes are to be sold to repackager/relabeler establishments for EtO sterilization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Drapes are provided as below
| Drape Model Family | Drape Name | Model Code (Sterile/Nonsterile) | Color | Drape Materials |
|---|---|---|---|---|
| Angiography Drapes | Angiography Surgical Drape | 935101/835101 | Blue | SMS base panel with SM pad and polyethylene sides |
| Fenestrated Drape | Clear Legging Surgical Drape | 935201/835201 | Clear | Polyethylene Film |
| Extremity Drapes | Universal Extremity Surgical Drape | 935301/835301 | Blue | SMS base panel with SM pad |
| Legging Surgical Drape | 935302/835302 | Blue | SMS panel | |
| Head Surgical Drape | 935303/835303 | Blue | SMS panel | |
| Side Surgical Drape | 935304/835304 | Blue | SMS base panel with SM pad | |
| Top Surgical Drape | 935305/835305 | Blue | SMS base panel with SM pad | |
| Bottom Surgical Drape | 935306/835306 | Blue | SMS base panel with SM pad | |
| Bar Surgical Drape | 935307/835307 | Blue | SMS base panel with SM pad | |
| Laparotomy Drapes | Laparotomy Surgical Drape | 935401/835401 | Blue | SMS base panel with SM pad |
| Arthroscopy Drapes | Arthroscopy Surgical Drape | 935501/835501 | Blue | SMS base panel with SM Pad and polyethylene pouch |
| Under buttocks Drapes | Under buttocks Surgical Drape | 935601/835601 | Blue | SMS base panel with SM Pad and polyethylene pouch |
| Split Drapes | Split Surgical Drape | 935701/835701 | Blue | SMS base panel with SM pad |
| Lithotomy Drapes | Lithotomy Surgical Drape | 935801/835801 | Blue | SMS base panel with SM pad |
| Laparoscopic Drapes | Laparoscopic Surgical Drape | 935901/835901 | Blue | SMS base panel with SM pad |
| Thyrold Drapes | Thyroid Surgical Drape | 936001/83001 | Blue | SMS base panel with SM pad |
| Abdominal Drapes | Abdominal Surgical Drape | 936101/836101 | Blue | SMS panel |
| C-section Drapes | C-section Surgical Drape | 936201/836201 | Blue | SMS base panel with polyethylene pouch |
| Minor Procedure Drapes | Minor Procedure Surgical Drape | 936301/836301 | Blue | SMS base panel with SM pad |
| Lap Chole Drape | Lap Chole Surgical Drape | 936401/836401 | Blue | SMS base panel with SM pad |
| Universal Spine Drapes | Universal Spine Surgical Drape | 936501/836501 | Blue | SMS base panel with SM pad |
| Cystoscopy Surgical Drape | Cystoscopy T Surgical Drape | 936601/836601 | Blue | SMS base panel with SM pad |
| Chest Surgical Drape | Chest Surgical Drape | 936701/836701 | Blue | SMS base panel with SM pad |
| Utility Surgical Drape | Utility Surgical Drape | 936801/836801 | Blue | SM absorbent panel |
| Ophthalmic Surgical Drape | 936901/836901 | Blue | SMS base panel with |
Page 1 of 2
3
| Cardiovascular Drape | Surgical Drape | 8372-03778 | polyethylene pouch | |
|---|---|---|---|---|
| Drape | 83710-781 | SM absorbent panel with a | ||
| polyethylene backing | ||||
| Aperture Surgical Drape | Aperture Surgical Drape | Blue | SM absorbent panel with a | |
| polyethylene backing |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 2 of 2
Elizabeth F. Claverie 2012.12.11 18:26:29 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:_
4
INDICATIONS FOR USE
510(k) Number (if known): K | 22 000
Device Name: HM Surgical Equipment Covers
Indications for Use:
HM Surgical Equipment Covers are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
HM surgical equipment covers are disposable, single use, sterile or nonsterile.
Non-sterile HM surgical equipment covers are to be sold to repackager/relabeler establishments for E!O sterflization according to ISO 11135-1 and sterile surgical drapes are to be sold directly to users after EtO sterilization validation to ISO 11135-1.
Drapes are provided as below
| Drape Model Family | Equipment Cover Name | Model Code (Sterile/Nonsterile) | Cover | Drape Materials |
|---|---|---|---|---|
| Equipment Cover | Band Bag | 938101/838101 | Clear | Polyethylene bag |
| Equipment Cover | Mayo Stand Cover | 938102/838102 | Blue | Blue polyethylene tube with SM reinforcement |
| Equipment Cover | Table Cover | 938103/838103 | Blue | Blue polyethylene film with SM reinforcement |
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Elizabeth F. Claverie 2012.12.11 18:25:53 -05'00'
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: