(229 days)
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Not Found
No
The 510(k) summary describes sterile surgical drapes and equipment covers, which are passive barrier devices. There is no mention of any computational or analytical capabilities, let alone AI/ML.
No
The device, surgical drapes and equipment covers, is intended to be a protective barrier and isolate a site from contamination, rather than to treat or cure a disease or condition.
No
The provided text describes surgical drapes and equipment covers, which are used for protection during surgery, not for diagnosing conditions or diseases.
No
The intended use and indications for use describe physical sterile surgical drapes and equipment covers, which are hardware devices, 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 devices are sterile surgical drapes and equipment covers. These are physical barriers used during surgery to prevent contamination.
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
The described devices do not involve testing samples from the body. They are physical barriers used in a surgical setting.
N/A
Intended Use / Indications for Use
proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
Product codes (comma separated list FDA assigned to the subject device)
KKX, MMP
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
Not Found
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
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.
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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.
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).
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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.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 20 2008
Mr. Leo Wei Director, Quality Assurance/Regulatory Affairs ProMEDICAL Product Company, Limited 206 Haung He Road West, New North District Changzhou, Jiangsu CHINA 213022
Re: K080629
Trade/Device Name: proMedical Surgical Drape proMedical Surgical Equipment Cover Regulation Number: 21 CFR 878.4370 Regulation Name: Surgical Drape and Drape Accessories Regulatory Class: II Product Code: KKX, MMP Dated: September 24, 2008 Received: October 1, 2008
Dear Mr. Wei:
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.
1
Page 2 - Mr. Wei
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 (240) 276-0115. 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 yours,
Cure
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, 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): K080629
Devise name: proMedical Surgical Drape
Indications for use:
proMedical Products Co. LTD intends to market sterile surgical drapes identified in 21 CFR 878.4370 as device made of natural or synthetic material intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination.
| Drape Model
Family | Drape Name | Model
Code | Drape Materials |
|----------------------------|---------------------------------------|---------------|----------------------------------------------------------------|
| Angiography
Drape | Angiography
Surgical Drape | 19-001 | SMS base panel with air-
laid pad and
polyethylene sides |
| Fenestrated
Drape | Clear Legging
Surgical Drape | 19-020 | Polyethylene panel |
| Extremity
Drape | Universal Extremity
Surgical Drape | 19-051 | SMS base panel with air-
laid pad |
| | Legging Surgical
Drape | 19-052 | SMS panel |
| | Head Surgical Drape | 19-053 | SMS panel |
| | Side Surgical Drape | 19-054 | SMS base panel with air-
laid pad |
| | Top Surgical Drape | 19-055 | SMS base panel with air-
laid pad |
| | Bottom Surgical
Drape | 19-056 | SMS base panel with air-
laid pad |
| | Bar Surgical Drape | 19-057 | SMS base panel with air-
laid pad |
| Laparotomy
Drape | Laparotomy Surgical
Drape | 19-100 | Spunlace base panel with
air-laid pad |
| Arthroscopy
Drape | Arthroscopy
Surgical Drape | 19-151 | SMS base panel with
polyethylene pouch |
| Under
buttocks
Drape | Under buttocks
Surgical Drape | 19-201 | SMS base panel with air-
laid Pad and
polyethylene pouch |
| Split Drapes | Split Surgical
Drape | 19-251 | SMS base panel with air-
laid pad |
| Lithotomy
Drape | Lithotomy Surgical
Drape | 19-301 | SMS base panel with air-
laid pad |
| Laparoscopic
Drape | Laparoscopic
Surgical Drape | 19-351 | SMS base panel with air-
laid pad |
| Thyroid
Drape | Thyroid Surgical
Drape | 19-401 | SMS base panel with air-
laid pad |
| Abdominal
Drape | Abdominal Surgical
Drape | 19-451 | SMS panel |
3
| Drape Model
Family | Drape Name | Model
Code | Drape Materials |
|-----------------------------------|-----------------------------------|---------------|------------------------------------------------------------|
| C-section
Drape | C-section Surgical
Drape | 19-501 | SMS base panel with
polyethylene pouch |
| Minor
Procedure
Drape | Minor Procedure
Surgical Drape | 19-551 | SMS base panel with air-
laid pad |
| Lap Chole
Drape | Lap Chole Surgical
Drape | 19-601 | SMS base panel with air-
laid pad |
| Universal
Spine Drape | Universal Spine
Surgical Drape | 19-651 | SMS base panel with air-
laid pad |
| Cystoscopy T
Surgical
Drape | Cystoscopy T
Surgical Drape | 19-701 | SMS base panel with air-
laid pad |
| Chest
urgical
Drape | Chest Surgical
Drape | 19-751 | SMS base panel with air-
laid pad |
| Utility
Surgical
Drape | Utility Surgical
Drape | 19-801 | Air-laid absorbent panel |
| Ophthalmic
Drape | Ophthalmic Surgical
Drape | 19-851 | SMS base panel with
polyethylene pouch |
| Cardiovascul
ar Drape | Cardiovascular
Surgical Drape | 19-901 | Air-laid absorbent panel
with a polyethylene
backing |
| Aperture
Drape | Aperture Surgical
Drape | 19-951 | Air-laid 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
..............................................................................................................................................................................
510(k) Number: K080629
4
Indications for Use
510(k) Number (if known): _K080629
Devise name: proMedical Surgical Equipment Cover
Indications for use:
proMedical Products Co. LTD intends to market Sterile surgical equipment covers which are protective barrier covers that are intended to be used to cover surgical equipment and provide a protective barrier for that equipment.
| Cover Name | Model
Code | Cover Materials |
|---------------------|---------------|-------------------------------------------------------|
| Band Bag | 14-001 | Polyethylene bag |
| Mayo Stand
Cover | 15-001 | Blue polyethylene tube with Air-laid
reinforcement |
| Table Cover | 16-001 | Blue polyethylene film with Air-laid
reinforcement |
Shuly A. Mayles, MD
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
510(k) Number: K080629
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
. . . .